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Anesthesiology
Review Panel
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Review Panel
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Review Panel
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
GXO
Strip, Craniosynostosis, Preformed
2
Product Code
GXP
Methyl Methacrylate For Cranioplasty
2
Product Code
GXQ
Dura Substitute
2
Product Code
GXR
Cover, Burr Hole
2
Product Code
GXT
Monitor, Lesion Temperature
2
Product Code
GWO
Plate, Cranioplasty, Preformed, Alterable
2
Product Code
GXC
Device, Electroconvulsive Therapy
3
Product Code
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
2
Product Code
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
3
Product Code
GZA
Implanted Cerebellar Stimulator
3
Product Code
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
2
Product Code
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
2
Product Code
GZI
Stimulator, Neuromuscular, External Functional
2
Product Code
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
2
Product Code
K
23
2441
Unipro (K-UNIPRO-US)
2
Cleared 510(K)
K
24
1228
TENSWave
2
Cleared 510(K)
K
22
2879
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
2
Cleared 510(K)
K
21
2618
iRelieve Microcurrent Pain Relief System
2
Cleared 510(K)
K
21
3802
StimOnTM Pain Relief System (GM2439)
2
Cleared 510(K)
K
22
0578
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
2
Cleared 510(K)
K
22
0503
TENS device-EmeTerm 2, Model: YF-ZTY-E2
2
Cleared 510(K)
K
20
2893
Transcutaneous Electrical Nerve Stimulator
2
Cleared 510(K)
K
20
2186
TrueRelief Device
2
Cleared 510(K)
K
21
0202
BioWaveGO RX
2
Cleared 510(K)
K
20
1458
Scrambler Therapy Technology (Model ST-5A)
2
Cleared 510(K)
K
20
2159
actiTENS
2
Cleared 510(K)
K
20
1431
OGYILI TENS/NMES Stimulator
2
Cleared 510(K)
K
18
1645
StimaWELL 120MTRS
2
Cleared 510(K)
K
19
1547
ReliefBand
2
Cleared 510(K)
K
18
2960
ReliefBand
2
Cleared 510(K)
K
18
2025
ClearUP Sinus Pain Relief
2
Cleared 510(K)
K
18
0943
BioWaveGO
2
Cleared 510(K)
K
17
2478
TENS device-EmeTerm, CinvStop
2
Cleared 510(K)
K
17
3233
ReliefBand 1.5
2
Cleared 510(K)
K
16
1091
STIMPOD NMS460 Nerve Stimulator
2
Cleared 510(K)
K
16
2663
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
2
Cleared 510(K)
K
16
0246
SimulCare II(TM)
2
Cleared 510(K)
K
15
3704
Strive
2
Cleared 510(K)
K
15
2676
FD TENS 2090, FD TENS 2095
2
Cleared 510(K)
K
15
2437
BiowaveHOME Neuromodulation Pain Therapy Device
2
Cleared 510(K)
K
14
3198
Synapse Transcutaneous Electrical Stimulation Device
2
Cleared 510(K)
K
14
2666
Scrambler Therapy MC-5 A Device
2
Cleared 510(K)
K
13
1513
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
2
Cleared 510(K)
K
13
3779
CP RELIEF WAND
2
Cleared 510(K)
K
12
3099
Best-AV2 Pro-Sport(tm)
2
Cleared 510(K)
K
13
1675
BODIHEALTH SYSTEM
2
Cleared 510(K)
K
12
3958
JIAJIAN POINTOSELECT DIGITAL
2
Cleared 510(K)
K
13
0919
SENSUS
2
Cleared 510(K)
K
12
2948
GEM-STIM COMBO STIMULATOR
2
Cleared 510(K)
K
12
1369
NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
2
Cleared 510(K)
K
12
1305
STERLING MEDICAL IMPULSE 3 STIMULATOR
2
Cleared 510(K)
K
12
0398
WITOUCH PRO
2
Cleared 510(K)
K
12
1184
SENSUS
2
Cleared 510(K)
K
12
1578
ATOM 1 (MODEL: BRC 2200)
2
Cleared 510(K)
K
11
3544
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
2
Cleared 510(K)
K
12
0569
GEMORE TENS SYSTEM
2
Cleared 510(K)
K
12
0054
ULTIMA NEO
2
Cleared 510(K)
K
11
2288
JIAJIAN TENS
2
Cleared 510(K)
K
11
1654
FD TENS 2070
2
Cleared 510(K)
K
11
2258
NEUROTECH PLUS
2
Cleared 510(K)
K
11
2485
H-WAVE
2
Cleared 510(K)
K
11
1645
FD TENS 2050 OR SLIDE TENS MODEL FD2050
2
Cleared 510(K)
K
10
2278
QUADRA BLOC TENS PLUS
2
Cleared 510(K)
K
11
0350
KNEEHAB XP
2
Cleared 510(K)
K
11
0390
ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
2
Cleared 510(K)
K
10
0668
NEMA-ST, MODEL V1.0.2
2
Cleared 510(K)
K
10
2014
TENS STIMULATOR, MODELS 2800 AND 3000
2
Cleared 510(K)
K
10
0399
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
2
Cleared 510(K)
K
09
2448
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
2
Cleared 510(K)
K
09
1045
SMART TENS, MODEL: D-BC05T
2
Cleared 510(K)
K
09
2990
AMD 6605 TENS/NMES
2
Cleared 510(K)
K
09
0866
NEUROCALM MODEL 1 AND 2
2
Cleared 510(K)
K
08
3250
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
2
Cleared 510(K)
K
09
1236
MANTRA COMBO, MODEL MECS 320
2
Cleared 510(K)
K
09
1317
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
2
Cleared 510(K)
K
09
0922
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
2
Cleared 510(K)
K
09
0717
FLEX-TENS
2
Cleared 510(K)
K
08
3822
LASER TOUCHONE
2
Cleared 510(K)
K
08
1835
ACTICARE IC AND TSE
2
Cleared 510(K)
K
08
2190
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298
2
Cleared 510(K)
K
08
2057
DX6605E-TENS, DX6605E-G, DX6609-G
2
Cleared 510(K)
K
08
1255
SCRAMBLER ST 5 TENS DEVICE
2
Cleared 510(K)
K
08
2377
TENSCARE ITOUCH MODEL(S) EASY AND PLUS
2
Cleared 510(K)
K
08
3030
TENS-EMS-14
2
Cleared 510(K)
K
08
3494
ULTIMA FIVE
2
Cleared 510(K)
K
08
3202
COMBOCARE 2000
2
Cleared 510(K)
K
08
2011
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
2
Cleared 510(K)
K
08
2514
TENS/EMS COMBO, EMS, TENS
2
Cleared 510(K)
K
08
0221
EA STIMULATOR
2
Cleared 510(K)
K
08
1141
COMBOCARE 2000
2
Cleared 510(K)
K
08
0304
PRO TENS, MODEL WL-240 RX
2
Cleared 510(K)
K
07
1120
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
2
Cleared 510(K)
K
07
3008
KFH ENERGY, MODEL: E1
2
Cleared 510(K)
K
07
1869
TENS/IF 14
2
Cleared 510(K)
K
07
3438
PROSTIM 1000/2000
2
Cleared 510(K)
K
07
2123
HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
2
Cleared 510(K)
K
07
1878
DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB
2
Cleared 510(K)
K
07
1624
EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR
2
Cleared 510(K)
K
06
2003
NEURO WAVE 6
2
Cleared 510(K)
K
07
1951
COMFY SERIES: EV-804, EV-805 & EV-806
2
Cleared 510(K)
K
06
1828
LORENZ BIOTECH APTIVA, VERSION 2.13
2
Cleared 510(K)
K
07
0299
EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
2
Cleared 510(K)
K
06
2616
WELLNESSPRO 2010
2
Cleared 510(K)
K
06
2641
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
2
Cleared 510(K)
K
07
0474
NEWLIFE SCIENCES LLC, MODEL TMR
2
Cleared 510(K)
K
06
2547
QUADRA BLOC TENS, MODEL 101
2
Cleared 510(K)
K
05
2836
BODIHEALTH SYSTEM
2
Cleared 510(K)
K
06
1516
STAODYN MAX PRESET, MODEL 4470
2
Cleared 510(K)
K
06
1650
SELECT TENS, MODEL 4600S
2
Cleared 510(K)
K
06
0669
MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300
2
Cleared 510(K)
K
06
1799
QUADRATENS, MODEL QT-42
2
Cleared 510(K)
K
06
1476
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
2
Cleared 510(K)
K
05
2711
EMJOI TENS DEVICE
2
Cleared 510(K)
K
06
0517
POINTER EXCEL
2
Cleared 510(K)
K
06
0508
POINTER PLUS
2
Cleared 510(K)
K
06
0246
INFREX
2
Cleared 510(K)
K
05
0989
AWQ-104
2
Cleared 510(K)
K
06
0368
INSPIRSTAR IS02 MICROCURRENT STIMULATOR
2
Cleared 510(K)
K
05
3284
MAGBODY DT-600
2
Cleared 510(K)
K
05
1128
ELECTROPULSE
2
Cleared 510(K)
K
05
1020
ES-160
2
Cleared 510(K)
K
05
2813
FD TENS 2030, MODEL DFJ24T
2
Cleared 510(K)
K
05
2182
SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
2
Cleared 510(K)
K
05
0174
BIO-STIM KIT
2
Cleared 510(K)
K
05
0435
E-STIM II
2
Cleared 510(K)
K
04
2912
INTERX5000
2
Cleared 510(K)
K
05
0740
MICROWARE 200
2
Cleared 510(K)
K
04
2711
MODEL BMLS03-7
2
Cleared 510(K)
K
04
2107
TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001
2
Cleared 510(K)
K
04
1388
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
2
Cleared 510(K)
K
04
1172
BASBA E-MACHINE
2
Cleared 510(K)
K
04
2559
GEM-TWIN TENS/ MODELS GM3XY/Z
2
Cleared 510(K)
K
04
0311
SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331
2
Cleared 510(K)
K
04
1520
MANTRA TENS MODEL NT3
2
Cleared 510(K)
K
04
1359
BODY CLOCK STIMPLUS AND STIMPLUS PRO
2
Cleared 510(K)
K
04
1575
FENZIAN TREATMENT SYSTEM
2
Cleared 510(K)
K
04
1092
FAST START TENS, MODEL FS 3001
2
Cleared 510(K)
K
04
0512
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
2
Cleared 510(K)
K
04
1164
L-TENS
2
Cleared 510(K)
K
04
0193
MODEL GST-1
2
Cleared 510(K)
K
02
3916
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
2
Cleared 510(K)
K
04
0253
EASY MED TN-28 C
2
Cleared 510(K)
K
03
3455
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
2
Cleared 510(K)
K
03
2003
PREMIER PLUS
2
Cleared 510(K)
K
03
3857
T-TECH DIGITAL, MODEL WL-22XXA SERIES
2
Cleared 510(K)
K
03
2928
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
2
Cleared 510(K)
K
03
2994
GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)
2
Cleared 510(K)
K
03
2720
GEM-STIM TENS, MODELS GM3XY AND GM3AXY
2
Cleared 510(K)
K
03
1374
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
2
Cleared 510(K)
K
03
1546
RAINBOW GT-4A PAIN RELIEF MACHINE
2
Cleared 510(K)
K
03
3253
S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
2
Cleared 510(K)
K
03
2055
MEDS-4-INF+
2
Cleared 510(K)
K
03
2653
E275
2
Cleared 510(K)
K
02
3913
NEUROTECH BAXOLVE TYPE 294
2
Cleared 510(K)
K
02
3726
TENS PRO 900
2
Cleared 510(K)
K
02
2849
BODY CLOCK TENS N' TONE
2
Cleared 510(K)
K
02
1952
HIVOX DREAMATE DM-800
2
Cleared 510(K)
K
02
2417
CARE STIM
2
Cleared 510(K)
K
02
3231
ELFCARE DEVICE, MODELS 314A THROUGH 314G
2
Cleared 510(K)
K
03
0537
DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
2
Cleared 510(K)
K
03
0140
DUOMED, SERIES 500, (MODELS ID 500, FL 500)
2
Cleared 510(K)
K
02
1271
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3
2
Cleared 510(K)
K
02
1270
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2
2
Cleared 510(K)
K
02
3443
MEDS-3 NEUROMUSCULAR STIMULATOR
2
Cleared 510(K)
K
02
3435
MEDS-4 NEUROMUSCULAR STIMULATOR
2
Cleared 510(K)
K
02
1794
TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING)
2
Cleared 510(K)
K
02
0020
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
2
Cleared 510(K)
K
02
1430
SANIDAD TENS-DUO MODE GP8016N
2
Cleared 510(K)
K
02
1846
804SIII; 804W; LIBRA TENS; 410; S-TENS II
2
Cleared 510(K)
K
02
2925
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
2
Cleared 510(K)
K
02
2841
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
2
Cleared 510(K)
K
02
2731
V TENS PLUS
2
Cleared 510(K)
K
02
0749
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
2
Cleared 510(K)
K
02
2076
FIRST CHOICE & FIRST CHOICE PLUS
2
Cleared 510(K)
K
02
0712
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
2
Cleared 510(K)
K
01
3532
ULTRASTIM KIT
2
Cleared 510(K)
K
02
2405
MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC
2
Cleared 510(K)
K
02
1496
HMS-DHR-3 NEUROMUSCULAR STIMULATOR
2
Cleared 510(K)
K
02
1436
TTECH MODEL 200E + TENS DEVICE
2
Cleared 510(K)
K
01
1891
PANAG
2
Cleared 510(K)
K
01
4020
NT MEDITENS PLUS, TYPE 290
2
Cleared 510(K)
K
02
1755
APEX MEDICAL DIGITAL TENS TS1211, TS1212
2
Cleared 510(K)
K
02
0803
CEFAR MEDICAL AB CEFAR PRIMO
2
Cleared 510(K)
K
02
0846
ULTIMA TENS XL-A1
2
Cleared 510(K)
K
01
4126
SANIDAD HEALTH-UP TENS MP-73725
2
Cleared 510(K)
K
02
1359
DIGI-PRO TENS MODEL WL-2203 AND WL-2205
2
Cleared 510(K)
K
01
3210
TRUWAVE
2
Cleared 510(K)
K
02
0180
RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL
2
Cleared 510(K)
K
02
0437
CLASSIC TENS
2
Cleared 510(K)
K
00
3744
ENRAF-NONIUS ENDOMED 182 SYSTEM
2
Cleared 510(K)
K
02
0032
APEX MEDICAL MINI TENS
2
Cleared 510(K)
K
01
3167
MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500
2
Cleared 510(K)
K
01
3507
COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
2
Cleared 510(K)
K
00
4008
STRESS GUARD, MODEL HERDEV1
2
Cleared 510(K)
K
01
2643
APEX MEDICAL LCD TENS-VII
2
Cleared 510(K)
K
01
2848
WINNER CM4 COMBINATION UNIT
2
Cleared 510(K)
K
01
0615
CYCLOTEC AMT CTI TENS DEVICE
2
Cleared 510(K)
K
01
1017
PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT
2
Cleared 510(K)
K
01
1543
TENS CARE, MODEL XL-Y3
2
Cleared 510(K)
K
01
0203
ACCU-PULSE TENS UNIT
2
Cleared 510(K)
K
01
0295
MICROSTIM 100I TENS DEVICE
2
Cleared 510(K)
K
00
2874
WELL-TENS
2
Cleared 510(K)
K
01
0209
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
2
Cleared 510(K)
K
00
1897
MULTI-STIM, MODEL MS-100
2
Cleared 510(K)
K
01
0782
TRANSAMERICAN TENS
2
Cleared 510(K)
K
00
2297
YORAMED, MODEL T-202
2
Cleared 510(K)
K
00
3369
LIFECARE COMPACT TENS DEVICE
2
Cleared 510(K)
K
00
3507
MEDRELIEF
2
Cleared 510(K)
K
00
3591
TENSCARE, MODEL TENS XL-2
2
Cleared 510(K)
K
99
3229
ANALGESIC PULSER, MODEL AP-439
2
Cleared 510(K)
K
00
3487
STIMATE N601 TENS
2
Cleared 510(K)
K
00
3258
MS-ONE, MODEL MS-1
2
Cleared 510(K)
K
00
3231
HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3
2
Cleared 510(K)
K
99
4266
FDTENS 2010
2
Cleared 510(K)
K
99
4265
MEDISANA DIGITAL TENS
2
Cleared 510(K)
K
98
4376
ENDOR 2000
2
Cleared 510(K)
K
99
4387
RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
2
Cleared 510(K)
K
99
1397
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
2
Cleared 510(K)
K
98
3907
RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
2
Cleared 510(K)
K
99
3823
MED-4000
2
Cleared 510(K)
K
99
2709
1818 TENS UNIT
2
Cleared 510(K)
K
99
0230
ELECTRO-NERVE STIMULATOR TENS, MODEL LX
2
Cleared 510(K)
K
98
2961
MEDIPOINT
2
Cleared 510(K)
K
98
2173
BUZBEE
2
Cleared 510(K)
K
98
2967
RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R
2
Cleared 510(K)
K
98
4025
CARE TENS
2
Cleared 510(K)
K
98
2324
VECTRA PRO MODELS 2 AND 4
2
Cleared 510(K)
K
98
2321
VECTRA STIM MODELS 200 AND 400
2
Cleared 510(K)
K
98
1976
ACUTRON MENTOR MODEL 961
2
Cleared 510(K)
K
98
2410
SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE
2
Cleared 510(K)
K
98
2436
RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R
2
Cleared 510(K)
K
98
2221
PREMIER AP
2
Cleared 510(K)
K
96
4437
GB-1002 TENS WITH MASSAGE
2
Cleared 510(K)
K
97
3979
MULTI-STIM TENS, AP-101081T
2
Cleared 510(K)
K
97
3978
MICRO II MICROCURRENT TENS
2
Cleared 510(K)
K
97
3980
ACU-STIM TENS, AP-101082T
2
Cleared 510(K)
K
97
2244
NT2000
2
Cleared 510(K)
K
98
0333
RELIEFBAND
2
Cleared 510(K)
K
97
4497
INTELECT
2
Cleared 510(K)
K
96
5244
Z TECH TRANSCUTANEOUS NEURAL STIMULATION
2
Cleared 510(K)
K
96
2951
MODEL HS-2 TENS DEVICE
2
Cleared 510(K)
K
96
5187
SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
2
Cleared 510(K)
K
96
1050
RELIEFBAND TENS UNIT (MODIFICATION)
2
Cleared 510(K)
K
94
0954
SYNAPTIC 3000
2
Cleared 510(K)
K
97
0429
BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
2
Cleared 510(K)
K
95
3982
SIMPLEX TENS
2
Cleared 510(K)
K
97
0203
EPIX VT
2
Cleared 510(K)
K
96
3507
EXTRA TENS (RI-2500) NEO TENS (RI-2000E)
2
Cleared 510(K)
K
97
0696
S.P. 100
2
Cleared 510(K)
K
96
1809
SHE-LI TENS STIMULATOR MODEL SL-101 RX
2
Cleared 510(K)
K
96
3729
SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
2
Cleared 510(K)
K
96
3125
M AND R REUSABLE ELECTRODES (MULTIPLE)
2
Cleared 510(K)
K
95
5470
ACTION POTENTIAL SIMULATION THERAPY DEVICE
2
Cleared 510(K)
K
96
1376
SMART-TENS, MODEL 456
2
Cleared 510(K)
K
96
2910
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
2
Cleared 510(K)
K
96
2332
TENS/FES/NMES ELECTRODES
2
Cleared 510(K)
K
96
1749
TRANSAMERICA ELECTRODE
2
Cleared 510(K)
K
95
4951
TAYLOR GENERAL PURPOSE MONITORING ELECTRODE
2
Cleared 510(K)
K
95
1951
FOCUS MODEL 795 UNIT
2
Cleared 510(K)
K
96
0969
GALVA 5-T
2
Cleared 510(K)
K
95
1903
EPIX XL TENS UNIT
2
Cleared 510(K)
K
95
4334
ACUPLUS
2
Cleared 510(K)
K
94
6230
ENDURA REUSABLE TENS AND NMES ELECTRODES
2
Cleared 510(K)
K
94
2631
ELECTROCARE
2
Cleared 510(K)
K
94
0600
STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ
2
Cleared 510(K)
K
94
6299
PGS123 AND HVS-123
2
Cleared 510(K)
K
94
1923
STERILE TREATMENT ELECTRODE
2
Cleared 510(K)
K
93
3197
THE SIGNATURE SERIES, M IV
2
Cleared 510(K)
K
94
4280
TRANSAMERICAN CLASSIC TENS
2
Cleared 510(K)
K
94
5676
GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES
2
Cleared 510(K)
K
93
3237
MEDI-STIM, MODIFICATION
2
Cleared 510(K)
K
93
4051
BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
2
Cleared 510(K)
K
93
2897
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
2
Cleared 510(K)
K
93
1079
STAT-TENS
2
Cleared 510(K)
K
93
3368
TENS-IT
2
Cleared 510(K)
K
93
5324
THERAPEUTIC ULTRASOUND AND STIMULATOR
2
Cleared 510(K)
K
93
5395
NEURON II AND MICROTENS
2
Cleared 510(K)
K
93
0102
PULSATOR 5000
2
Cleared 510(K)
K
93
2592
BRACE NEUTRALIZER
2
Cleared 510(K)
K
93
5132
HOME MICROCURRENT HMC
2
Cleared 510(K)
K
93
4619
FLEXMATE
2
Cleared 510(K)
K
93
2854
EZ GRIP DISPOSABLE ELECTRODES
2
Cleared 510(K)
K
93
1108
EZ GRIP REUSABLE TENS/NMES ELECTRODES
2
Cleared 510(K)
K
93
2611
NEUROMUSCULAR STIMULATOR
2
Cleared 510(K)
K
93
2849
PMI TENS ELECTRODE
2
Cleared 510(K)
K
93
1715
PURECARE AT-903 T.E.N.S.
2
Cleared 510(K)
K
93
2320
NEUTRALIZER
2
Cleared 510(K)
K
93
1570
COM-TENS (SINGLE MODE)
2
Cleared 510(K)
K
93
1424
MAXIMA I
2
Cleared 510(K)
K
92
6326
MICROCARE(TM)
2
Cleared 510(K)
K
92
3970
INTEGRITY 2
2
Cleared 510(K)
K
92
2202
K-STIM CLEAR
2
Cleared 510(K)
K
93
0865
STAODYN MAXIMA III
2
Cleared 510(K)
K
92
5821
COMFORTRON
2
Cleared 510(K)
K
91
5663
TENS PRO 900
2
Cleared 510(K)
K
92
5686
THERA PULSE A ELECTRO NERVE STIMULATOR
2
Cleared 510(K)
K
92
5898
MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS
2
Cleared 510(K)
K
92
5729
SD-602 SD MODE 11, SD-603 SD MOD 111
2
Cleared 510(K)
K
92
0266
TENS MODEL 240Z
2
Cleared 510(K)
K
92
4545
MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR
2
Cleared 510(K)
K
92
3934
TX-3 SD
2
Cleared 510(K)
K
92
3935
SD-605 SD II PROGRAM
2
Cleared 510(K)
K
92
3298
MICRO 100,200,300, & 400 TENS
2
Cleared 510(K)
K
92
2690
PAIN-EEZ
2
Cleared 510(K)
K
92
0260
INTELECT 600MP
2
Cleared 510(K)
K
92
1679
K-DISPERSE
2
Cleared 510(K)
K
92
3255
Q-SD
2
Cleared 510(K)
K
92
1828
TEAM-MC II
2
Cleared 510(K)
K
92
1813
MED-TENS
2
Cleared 510(K)
K
92
1110
TENS
2
Cleared 510(K)
K
91
5210
ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A
2
Cleared 510(K)
K
91
2381
LOW BACK STRIP (OR) K-BACK
2
Cleared 510(K)
K
91
0727
EXCEL MODEL 2110
2
Cleared 510(K)
K
91
4813
THERASTIM
2
Cleared 510(K)
K
91
4871
TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
2
Cleared 510(K)
K
91
4441
MENS 2000-D
2
Cleared 510(K)
K
91
1963
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
2
Cleared 510(K)
K
91
3532
TX 3 TENS MODIFIED
2
Cleared 510(K)
K
91
2289
ULTIMA XS, MODIFICATION
2
Cleared 510(K)
K
90
1704
RELIEF BAND (T.E.N.S. DEVICE)
2
Cleared 510(K)
K
91
2463
MICRO-Q
2
Cleared 510(K)
K
91
2460
Q-TENS
2
Cleared 510(K)
K
91
2178
BIO TENS 601, 606 AND 608 (3000)
2
Cleared 510(K)
K
91
1814
AXION 5, MODIFICATION
2
Cleared 510(K)
K
90
5672
TEAM-MC
2
Cleared 510(K)
K
91
3800
MEDA CROWN SERIES
2
Cleared 510(K)
K
91
3522
SOLITENS MODIFIED
2
Cleared 510(K)
K
91
3594
DYNEX IIIB, MODEL 89002026
2
Cleared 510(K)
K
91
0244
GLOBAL CARE MICRO II
2
Cleared 510(K)
K
91
2348
SX90 (TM),MODEL 4800S
2
Cleared 510(K)
K
90
5526
AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR
2
Cleared 510(K)
K
91
0580
MICROSTIM 100 MODEL 2C
2
Cleared 510(K)
K
90
2226
MY-O-MATIC 5000I
2
Cleared 510(K)
K
90
5570
ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A
2
Cleared 510(K)
K
90
5377
ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A
2
Cleared 510(K)
K
90
5230
ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A
2
Cleared 510(K)
K
90
4388
POINTER F-3 TENS
2
Cleared 510(K)
K
90
2102
COM-TENS: A NEUROSTIMULATOR
2
Cleared 510(K)
K
90
4288
MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS
2
Cleared 510(K)
K
90
4260
MENS-O-MATIC 3000
2
Cleared 510(K)
K
90
4258
MICRO DERM
2
Cleared 510(K)
K
90
4234
MENS-O-MATIC I
2
Cleared 510(K)
K
90
4430
MENS FREEDOM MICRO
2
Cleared 510(K)
K
90
4235
MENS-O-MATIC 2000
2
Cleared 510(K)
K
90
4264
MODEL SW-103 SOLITANS STIMULATOR
2
Cleared 510(K)
K
90
3394
GLOBALCARE MICRO 11 AND MICROCARE (TENS)
2
Cleared 510(K)
K
90
4457
DIAL-AWAY PAIN
2
Cleared 510(K)
K
90
3161
MC II (TM), MODEL 7200S
2
Cleared 510(K)
K
90
3577
DYNATRON 200 MICROCURRENT
2
Cleared 510(K)
K
90
3828
SYNAPS (TM)
2
Cleared 510(K)
K
90
3128
STIMTRAC PC, CATALOG NO. 78-8510
2
Cleared 510(K)
K
90
2822
MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE
2
Cleared 510(K)
K
89
6825
TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR
2
Cleared 510(K)
K
90
3017
MEGA-TENS DUAL CHANNEL T.E.N.S.
2
Cleared 510(K)
K
89
6408
QUANTUM
2
Cleared 510(K)
K
90
1417
ELECTROSTIM MST
2
Cleared 510(K)
K
90
1726
LUMISCOPE MICRO 100
2
Cleared 510(K)
K
89
6787
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
2
Cleared 510(K)
K
90
0668
ACUDATA INDICATENS MODEL 5XS
2
Cleared 510(K)
K
90
0596
ACUDATA INDICATENS MODEL 5A
2
Cleared 510(K)
K
89
6620
NEUROTENS
2
Cleared 510(K)
K
89
6226
LISS BODY STIMULATOR MODEL SBL501-M
2
Cleared 510(K)
K
89
6948
ALPHA-STIM CS
2
Cleared 510(K)
K
88
3911
ELECTRO-ACUSCOPE 85
2
Cleared 510(K)
K
89
5289
MEC-I-TRON MINI, MODEL M-2
2
Cleared 510(K)
K
89
5183
REBOX II (TENS)
2
Cleared 510(K)
K
89
5977
ACUSOURCE 600 (TENS)
2
Cleared 510(K)
K
89
4964
K-2 TENS OR MED TENS
2
Cleared 510(K)
K
89
5473
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
2
Cleared 510(K)
K
89
5295
ULTIMA XS MICROCURRENT TENS
2
Cleared 510(K)
K
89
5334
TTS2600
2
Cleared 510(K)
K
89
5161
TTS2800
2
Cleared 510(K)
K
89
5166
TTS2500
2
Cleared 510(K)
K
89
5211
TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
2
Cleared 510(K)
K
88
3811
ELECTRONIC PAIN RELIEVERS
2
Cleared 510(K)
K
89
1992
TENZCARE STIMULATOR 6890
2
Cleared 510(K)
K
89
0087
ACUDATA INDICATENS MODEL 5M
2
Cleared 510(K)
K
89
4127
LUMISCOPE MODEL 1000/APCC MODEL 1000
2
Cleared 510(K)
K
89
1118
STERLING TENS
2
Cleared 510(K)
K
89
4388
ZIMMER TENS
2
Cleared 510(K)
K
88
4972
TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
2
Cleared 510(K)
K
89
2408
NSD 8CS8 - TENS DEVICE
2
Cleared 510(K)
K
88
4869
MODIFIED MRL NEUROPROBE SYSTEM V
2
Cleared 510(K)
K
89
0604
EMPI, MODEL 489, TENS
2
Cleared 510(K)
K
89
0088
ACUDATA INDICATENS MODEL 5X
2
Cleared 510(K)
K
88
5190
MICRO-STIM 200
2
Cleared 510(K)
K
88
2980
REBUILDER BUCKET SYSTEM
2
Cleared 510(K)
K
89
0705
MEDIMOD(TM), MODEL 8900
2
Cleared 510(K)
K
88
4833
ULTRA 2000 (T.E.N.S.)
2
Cleared 510(K)
K
88
0744
ANESTY 10
2
Cleared 510(K)
K
88
3188
T.E.N.S. UNIT SIGMA & TX-3
2
Cleared 510(K)
K
88
4210
TX-7 (TENS) (IC-1107)
2
Cleared 510(K)
K
88
3236
CEFAR DUAL
2
Cleared 510(K)
K
88
4032
MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
2
Cleared 510(K)
K
88
2154
HEPAX (TENS)
2
Cleared 510(K)
K
87
4818
TENSTAR
2
Cleared 510(K)
K
88
2631
EMPI MODEL 727,NMS
2
Cleared 510(K)
K
87
5072
MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM
2
Cleared 510(K)
K
88
0426
ELECTROSTIMULATOR MODEL 808
2
Cleared 510(K)
K
88
1753
ALPHA-STIM 350
2
Cleared 510(K)
K
88
2820
MEDIPAC II EC (TM), MODEL 7900
2
Cleared 510(K)
K
88
2943
MEDA ONE-STEP
2
Cleared 510(K)
K
88
1708
INDICATENS 4X4
2
Cleared 510(K)
K
88
0042
ACUTRON
2
Cleared 510(K)
K
88
1832
DS-200 AND DS-400 T.E.N.S.
2
Cleared 510(K)
K
88
1704
EASY TENS
2
Cleared 510(K)
K
88
0492
INTERCEPT T.E.N.S. DEVICE
2
Cleared 510(K)
K
88
1114
EMPI MODEL 989, TENS
2
Cleared 510(K)
K
88
1424
PREMIER 10S (TENS)
2
Cleared 510(K)
K
88
0980
SCHULDT* PC* - DUAL CHANNEL TENS
2
Cleared 510(K)
K
88
0751
ULTIMA XS (TENS)
2
Cleared 510(K)
K
88
0452
LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE
2
Cleared 510(K)
K
87
2704
AMASTIM 2000
2
Cleared 510(K)
K
87
3190
MEC-I-TRON, MODEL P-1
2
Cleared 510(K)
K
87
4085
REBUILDER(TM)
2
Cleared 510(K)
K
87
4550
TX-4(TENS) (SIGMA TENS)
2
Cleared 510(K)
K
87
4333
TX-2(TENS)
2
Cleared 510(K)
K
87
3357
ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA.
2
Cleared 510(K)
K
87
3420
GLOBALCARE(TENS)
2
Cleared 510(K)
K
87
3484
120Z(TENS)
2
Cleared 510(K)
K
87
2657
ULTRAPAC II SX PLUS (TM)
2
Cleared 510(K)
K
87
2398
T.E.N.S. DEVICE MODEL SPL 2000
2
Cleared 510(K)
K
87
2399
T.E.N.S. DEVICE MODEL SPL 2000S
2
Cleared 510(K)
K
87
1722
MEDTENS(TM), MODEL NUMBER 7725
2
Cleared 510(K)
K
87
1699
TX-3(TENS)
2
Cleared 510(K)
K
87
1666
MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR
2
Cleared 510(K)
K
87
1396
ACCULATOR 287EP
2
Cleared 510(K)
K
87
1125
ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN
2
Cleared 510(K)
K
87
1126
ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C
2
Cleared 510(K)
K
87
0667
OMEGA T200
2
Cleared 510(K)
K
87
0666
OMEGA T100
2
Cleared 510(K)
K
86
4370
DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)
2
Cleared 510(K)
K
87
0168
EMPI LOGIX MODEL 712 NMS, TENS
2
Cleared 510(K)
K
86
4114
TENS DEVICE FOR RELIEF OF CHRONIC PAIN
2
Cleared 510(K)
K
86
2454
AGAR 7K TENS INSTRUMENT
2
Cleared 510(K)
K
87
0583
NEU-PULS(TENS) MODEL #295
2
Cleared 510(K)
K
86
5063
UNI-PULS(TENS) MODEL #292
2
Cleared 510(K)
K
86
4968
BACPAC (TM), MODEL 6500
2
Cleared 510(K)
K
86
4956
DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
2
Cleared 510(K)
K
86
5048
ECLIPSE+, MODEL NUMBER 7723
2
Cleared 510(K)
K
86
4368
SCHULDT* PLUS 8 T.E.N.S. DEVICE
2
Cleared 510(K)
K
86
4735
A-TENS - MODEL AI-87
2
Cleared 510(K)
K
86
3469
CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
2
Cleared 510(K)
K
86
2352
ACCULATOR 487E
2
Cleared 510(K)
K
86
2602
AXION IV GOLDLINE SERIES
2
Cleared 510(K)
K
86
2450
MEDA 2500 T.E.N.S.
2
Cleared 510(K)
K
86
3567
'TENSAID'
2
Cleared 510(K)
K
86
3568
'MYOSTIM EX'
2
Cleared 510(K)
K
86
1896
UNI-TENS XL TENS
2
Cleared 510(K)
K
86
1895
UNI-TENS
2
Cleared 510(K)
K
86
1894
AGAR 9K TENS
2
Cleared 510(K)
K
86
2355
TRANS-PULSE MODEL #1103
2
Cleared 510(K)
K
86
2337
ULTRAPAC II SD (TM)
2
Cleared 510(K)
K
86
1119
WALLANT NEUROLOGIX DUAL PUR NERVE/NEUROMUSCU STIMU
2
Cleared 510(K)
K
86
0847
WALLANT NEUROLOGIX GENERAL PURPOSE TENS
2
Cleared 510(K)
K
85
2061
PULSAR NEUROSTIMULATOR
2
Cleared 510(K)
K
86
1830
EMPI MODEL GLS 450, TENS
2
Cleared 510(K)
K
86
1451
EMPI MODEL 720 NMS, TENS
2
Cleared 510(K)
K
86
1214
SKYLARK GB 1000
2
Cleared 510(K)
K
85
3898
SKYLARK MODEL 1001 TENS DEVICE
2
Cleared 510(K)
K
86
1709
A TENS (MODEL AI-86)
2
Cleared 510(K)
K
86
0772
HARIKY, MODEL GK-7
2
Cleared 510(K)
K
86
1501
EXER-STIM 2
2
Cleared 510(K)
K
85
4316
FASTENS(TM)
2
Cleared 510(K)
K
85
4476
KALMATE MODEL 3A
2
Cleared 510(K)
K
85
3992
VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
2
Cleared 510(K)
K
85
4761
MINIPAC PERSONAL TOUCH (TM)
2
Cleared 510(K)
K
85
3885
MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA
2
Cleared 510(K)
K
85
4317
MINIPAC (TM)
2
Cleared 510(K)
K
85
0855
TENS GB1001 DEVICE
2
Cleared 510(K)
K
85
3836
NEURO PULSE II
2
Cleared 510(K)
K
85
3442
MODEL 804 (TENS)
2
Cleared 510(K)
K
85
3719
TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410
2
Cleared 510(K)
K
85
3718
TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804
2
Cleared 510(K)
K
85
1735
SYS STIM 206 MODEL ME206
2
Cleared 510(K)
K
85
3416
MES-TENS(TENS)
2
Cleared 510(K)
K
85
2838
ADVANCED MEDICAL PRODUCTS MES TENS
2
Cleared 510(K)
K
85
2837
ADVANCED MEDICAL PRODUCTS DR PULSE (TENS)
2
Cleared 510(K)
K
85
2836
ADVANCED MEDICAL PRODUCTS MINI-M (TENS)
2
Cleared 510(K)
K
84
4618
BIO-TENS
2
Cleared 510(K)
K
85
1511
ACCURATECARE I & ACCURATECARE II
2
Cleared 510(K)
K
85
1063
TENSMED II
2
Cleared 510(K)
K
85
1191
ELECTRO-NERVE STIMULATOR DISCO B9 TENS
2
Cleared 510(K)
K
85
0860
AXON II BRAND OF DUAL CHANNEL TENS
2
Cleared 510(K)
K
85
1185
ELECTRO-NERVE STIMULATOR B4/B400
2
Cleared 510(K)
K
84
4680
CYBERTENS
2
Cleared 510(K)
K
85
0004
TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF
2
Cleared 510(K)
K
84
4994
THE MEHESZ STIMULATING SYSTEM
2
Cleared 510(K)
K
84
1427
ACCU-O-MATIC
2
Cleared 510(K)
K
84
4279
INTERCEPTOR, 662-01
2
Cleared 510(K)
K
84
4076
ELECTRO-NERVE STIMULATOR B5/SK700B
2
Cleared 510(K)
K
84
2888
DUAL CHANNEL TENS, PULSAR REMOTE CONTRL
2
Cleared 510(K)
K
84
4212
STIMTECH SD CLINICIAN 6090 #78-8055
2
Cleared 510(K)
K
84
4213
STIMTECH SD PATIENT 6089 #78-8050
2
Cleared 510(K)
K
84
4638
ELECTROCAINE MODEL SR-IV
2
Cleared 510(K)
K
84
3637
HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI
2
Cleared 510(K)
K
84
0099
MODEL 800-A VERI/PPR
2
Cleared 510(K)
K
84
3822
MEA110
2
Cleared 510(K)
K
84
3793
A-T TENS BELT
2
Cleared 510(K)
K
84
1184
ELECTRO-NERVE STIMULATOR HL
2
Cleared 510(K)
K
84
3119
ETI TENS BELT
2
Cleared 510(K)
K
84
2812
MENTOR 150 PLUS TRANSCUTANEOUS ELEC.
2
Cleared 510(K)
K
84
2414
ECHO PULSE BURST
2
Cleared 510(K)
K
84
0098
MODEL 811 VERI/TENS & PO
2
Cleared 510(K)
K
84
1400
NEURO PULSE
2
Cleared 510(K)
K
84
0964
SD PLUS CLINICIAN CAT# 78-8015
2
Cleared 510(K)
K
84
0963
SD PLUS PATIENT CAT.#78-8010
2
Cleared 510(K)
K
84
0497
OBSTETRIC PULSAR TWO CHANNEL TENS
2
Cleared 510(K)
K
84
1045
EMPI MODEL 984 BASIX, TENS
2
Cleared 510(K)
K
84
1000
BET MODEL 1010
2
Cleared 510(K)
K
84
0599
MULTI-STIMT
2
Cleared 510(K)
K
84
0821
TRNS MI 8202
2
Cleared 510(K)
K
83
3251
MODEL MK II TENS
2
Cleared 510(K)
K
83
4334
MEDAID DUAL CHANNEL TENS
2
Cleared 510(K)
K
84
0040
HEALTH-UP
2
Cleared 510(K)
K
83
3086
NEUROTRON 100
2
Cleared 510(K)
K
83
4215
MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM
2
Cleared 510(K)
K
83
1938
TRANSCUTANEOUS ELECTRONIC NERVE STIMU
2
Cleared 510(K)
K
83
3037
POINTER F-3
2
Cleared 510(K)
K
83
3354
AUTO-TENS MODEL VI DUAL CHANNEL BATT
2
Cleared 510(K)
K
83
1990
NEUROFLAX, EPK
2
Cleared 510(K)
K
83
2160
ELECTRO-PULSE
2
Cleared 510(K)
K
83
2442
ELECTRO-ACUSCOPE
2
Cleared 510(K)
K
83
2851
AGAR 8000 TENS
2
Cleared 510(K)
K
83
1487
ELECTRONEURAL STIMULATOR 12
2
Cleared 510(K)
K
83
2337
AUTO-TENS MODEL V
2
Cleared 510(K)
K
83
2238
NEUROMOD COMFORT WAVE #7721 DUAL-
2
Cleared 510(K)
K
83
0992
XCEL MODEL XE-1
2
Cleared 510(K)
K
83
1950
PULSAR #B SINGLE CHANNEL TENS-PULSAR D
2
Cleared 510(K)
K
83
1850
NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE
2
Cleared 510(K)
K
83
1147
OMNIPROBE ELECTRICAL NERVE STIMULATOR
2
Cleared 510(K)
K
83
1145
ALPHA-STIM 350
2
Cleared 510(K)
K
83
1144
ALPHA-STIM 2000
2
Cleared 510(K)
K
83
1413
SPEC IISX
2
Cleared 510(K)
K
83
0747
PC 2909A-HEALTH PULSE CONTROL STIMULATOR
2
Cleared 510(K)
K
83
0932
NYNEX II
2
Cleared 510(K)
K
83
0792
PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE
2
Cleared 510(K)
K
82
3466
AUTO-TENS MODEL III DUAL CHANNEL REPLACE
2
Cleared 510(K)
K
82
3467
AUTO-TENS MODEL I DISPOS. SINGLE CHAN
2
Cleared 510(K)
K
82
3465
AUTO-TENS MODEL II SINGLE CHANNEL
2
Cleared 510(K)
K
82
3464
AUTO-TENS MODEL IV -DUAL CHANNEL FULL
2
Cleared 510(K)
K
82
3742
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL
2
Cleared 510(K)
K
82
3497
WRIGHT CARE
2
Cleared 510(K)
K
82
3299
MODEL 402P SEQUENCER FOR EMPI TEMS DEV
2
Cleared 510(K)
K
82
3002
DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE
2
Cleared 510(K)
K
82
2929
VERIL/PPR PERSONAL PAIN RELIEVER #800
2
Cleared 510(K)
K
82
2841
THE EMD TENZ PAIN CONTROL SYSTEM
2
Cleared 510(K)
K
82
2854
PRO MED 100
2
Cleared 510(K)
K
82
2600
NEUROMEDICS ORIONS #660-01
2
Cleared 510(K)
K
82
1571
TP440 ORTHOPROBE
2
Cleared 510(K)
K
82
1523
OMNI TENS
2
Cleared 510(K)
K
82
1363
TRANS-Q
2
Cleared 510(K)
K
82
0651
MODEL 860-1 VERI/PROBE
2
Cleared 510(K)
K
82
0326
BIGSTON TRANSCUTANEOUS NERVE STIMULAT
2
Cleared 510(K)
K
82
0678
SYSTEM 10
2
Cleared 510(K)
K
81
3601
E.W.L. P-TENS MODEL(TENS
2
Cleared 510(K)
K
82
0496
TENS MODEL 8201
2
Cleared 510(K)
K
81
3569
EMOTENS
2
Cleared 510(K)
K
81
2612
TNS MK I STIMULATOR
2
Cleared 510(K)
K
81
3283
10D (TENS DEVICE)
2
Cleared 510(K)
K
81
3501
TRANSCUTANEOUS ELEC. NERVE STIMULATOR
2
Cleared 510(K)
K
81
3100
BIO-STIMULATOR, MODEL 400
2
Cleared 510(K)
K
81
2432
HEALTH-UP
2
Cleared 510(K)
K
81
2704
NEUROMED SELECTRA #7720
2
Cleared 510(K)
K
81
2138
TENS DEVICE
2
Cleared 510(K)
K
81
1499
TENSMAX
2
Cleared 510(K)
K
81
2036
NEUROGAR III
2
Cleared 510(K)
K
81
1351
VERI-FIER
2
Cleared 510(K)
K
81
1939
VITATRON 88
2
Cleared 510(K)
K
81
1345
INSIGHT
2
Cleared 510(K)
K
81
1095
TRANSCUTANEOUS ELECTRICAL NERVE
2
Cleared 510(K)
K
81
0841
MEDAID
2
Cleared 510(K)
K
81
1224
MINISTIM
2
Cleared 510(K)
K
81
1012
TENS-O-MATIC
2
Cleared 510(K)
K
81
0593
NEUROPAC ULTRA I
2
Cleared 510(K)
K
80
3121
MENTOR 150 TRANSCUTANEOUS NERVE STIMULA
2
Cleared 510(K)
K
80
3113
MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT
2
Cleared 510(K)
K
80
2779
LOAD SENTINEL II, TRANS. ELEC. NERVE
2
Cleared 510(K)
K
80
2678
TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR
2
Cleared 510(K)
K
80
2507
TENSMATE EMPIMODEL 9980
2
Cleared 510(K)
K
80
2063
SPEMBLY 9000 & 9300
2
Cleared 510(K)
K
80
2227
ANASTIM II TRANSCUTANEOUS ELECTRICAL
2
Cleared 510(K)
K
80
1459
ELECTRO-ACUSCOPE-70
2
Cleared 510(K)
K
80
1576
NEUROGAR III-TRANSCUT. ELEC. NERVE STIM
2
Cleared 510(K)
K
80
0576
CYCLOPAC CP100 TENS BANDAGE
2
Cleared 510(K)
K
80
1112
EMPI MODEL 910S, TENS
2
Cleared 510(K)
K
80
0758
TENZCARE DUAL-CHANNEL STIMULATOR
2
Cleared 510(K)
K
80
0630
TYPE 4000 TRANSCUTANEOUS ELEC. STIM.
2
Cleared 510(K)
K
79
2473
THERAPETTE, MODEL NO MH-100
2
Cleared 510(K)
K
79
2502
TENS 4100
2
Cleared 510(K)
K
79
2522
MODEL 980D TENS NEUROPACER
2
Cleared 510(K)
K
79
2474
TENS 4500
2
Cleared 510(K)
K
79
2311
MEDTRONIC MODEL 7728 NEUROMOD
2
Cleared 510(K)
K
79
1834
NURITE II VRM DUAL (ELEC. NERVE STIM.)
2
Cleared 510(K)
K
79
1833
NURITE II VRM SINGLE (ELEC. NERVE STIM)
2
Cleared 510(K)
K
79
1187
MODEL 810 VERI/TGS
2
Cleared 510(K)
K
79
1158
STIMULATOR, ELECTRICAL NERVE
2
Cleared 510(K)
K
78
2164
STIMULATOR, MODEL 1-600 ELECTRIC NERVR
2
Cleared 510(K)
K
79
0011
STIMULATOR, MENTOR 100 NERVE
2
Cleared 510(K)
K
79
0189
ELECTREAT MODEL 250 TRANSCUTANEOUS STIM
2
Cleared 510(K)
K
78
2127
STIMULATOR, ELECTRICAL NERVE
2
Cleared 510(K)
K
78
2075
STIMULATOR, MODEL 7727
2
Cleared 510(K)
K
78
1829
NEUROPAC ULTRA II
2
Cleared 510(K)
K
78
1670
STIMULATOR, E.S.I. NEURO
2
Cleared 510(K)
K
78
1683
NURITE II, SINGLE
2
Cleared 510(K)
K
78
1565
ELECTRICAL NERVE STIMULATOR MODEL 6035
2
Cleared 510(K)
K
78
1277
STIMULATOR, NERVE, TRANSCUTANEOUS
2
Cleared 510(K)
K
78
0828
NURITE II
2
Cleared 510(K)
K
78
0698
STIMULATORS, NERVE, ELECTRICAL
2
Cleared 510(K)
K
78
0444
NERVTRON-RX
2
Cleared 510(K)
K
78
0186
NEUROMOD STIMULATOR MODEL 3723
2
Cleared 510(K)
K
77
2224
NERVE STIMULATOR, ELEC. TRANSCUTANEOUS
2
Cleared 510(K)
K
77
1885
IMPORTED PAIN CONTROL DEVICE
2
Cleared 510(K)
K
77
1122
VERI/CTGS MODEL 850
2
Cleared 510(K)
K
76
1053
ANODYNE II-ELECTRICAL NEURO STIMULATOR
2
Cleared 510(K)
HAX
Tong, Skull For Traction
2
Product Code
HBP
Clip, Implanted Malleable
2
Product Code
HBW
Fastener, Plate, Cranioplasty
2
Product Code
HBZ
Catheter, Intravascular Occluding
3
Product Code
HCB
Device, Aversive Conditioning
2
Product Code
HCC
Device, Biofeedback
2
Product Code
HCE
Clamp, Carotid Artery
2
Product Code
HCG
Device, Neurovascular Embolization
2
Product Code
HCH
Clip, Aneurysm
2
Product Code
JXG
Shunt, Central Nervous System And Components
2
Product Code
JXH
Methyl Methacrylate For Aneurysmorrhaphy
2
Product Code
JXI
Cuff, Nerve
2
Product Code
JXK
Cranial Electrotherapy Stimulator To Treat Depression
3
Product Code
JXL
Block, Bite
2
Product Code
LEL
Device, Sleep Assessment
2
Product Code
LHG
Electrode, Spinal Epidural
2
Product Code
LIH
Interferential Current Therapy
2
Product Code
MVA
Orthosis, Cranial
2
Product Code
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
2
Product Code
MZQ
Balloon, Detachable, For Neurovascular Occlusion
2
Product Code
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
2
Product Code
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
2
Product Code
NUF
Catheter, Neurovasculature, Occluding Balloon
3
Product Code
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
2
Product Code
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
2
Product Code
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
2
Product Code
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
2
Product Code
OAN
Orthosis, Cranial, Laser Scan
2
Product Code
OBP
Transcranial Magnetic Stimulator
2
Product Code
OBV
Eating Disorder Conditioning Tool
2
Product Code
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
2
Product Code
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
2
Product Code
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
2
Product Code
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
2
Product Code
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
F
Product Code
PBJ
Cranial Distraction System
2
Product Code
PCB
External Cerebrospinal Fluid (Csf) Diversion
2
Product Code
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
2
Product Code
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
2
Product Code
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
2
Product Code
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
2
Product Code
PLU
Thermal System For Insomnia
2
Product Code
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
2
Product Code
PUU
Temporary Coil Embolization Assist Device
2
Product Code
PVL
Endoscopic Shunt Placement Kit
2
Product Code
PVO
Lumbar Drainage Catheter Kit
2
Product Code
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
2
Product Code
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
2
Product Code
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
2
Product Code
QAR
Thermal Vestibular Stimulator For Headache
2
Product Code
QBC
External Upper Limb Tremor Stimulator
2
Product Code
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
2
Product Code
QFD
Tens For Sinus Pain
2
Product Code
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
2
Product Code
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
2
Product Code
QGL
Transcutaneous Nerve Stimulator For Adhd
2
Product Code
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
2
Product Code
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
2
Product Code
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
2
Product Code
QQC
Brain Stimulation Programming Planning Software.
2
Product Code
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
2
Product Code
OVP
Vibratory Counter-Stimulation
2
Product Code
QVO
Computerized Behavioral Therapy Device For Insomnia
2
Product Code
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
2
Product Code
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
2
Product Code
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 30 November 2024 at 11:09 am
NE
/
subpart-f—neurological-therapeutic-devices
/
GZJ
/
K180943
View Source
BioWaveGO
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180943
510(k) Type
Traditional
Applicant
Biowave Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/17/2018
Days to Decision
129 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
GXO
Strip, Craniosynostosis, Preformed
GXP
Methyl Methacrylate For Cranioplasty
GXQ
Dura Substitute
GXR
Cover, Burr Hole
GXT
Monitor, Lesion Temperature
GWO
Plate, Cranioplasty, Preformed, Alterable
GXC
Device, Electroconvulsive Therapy
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
GYZ
Stimulator, Intracerebral/Subcortical, Implanted
GZA
Implanted Cerebellar Stimulator
GZB
Stimulator, Spinal-Cord, Implanted (Pain Relief)
GZF
Stimulator, Peripheral Nerve, Implanted (Pain Relief)
GZI
Stimulator, Neuromuscular, External Functional
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
K
23
2441
Unipro (K-UNIPRO-US)
K
24
1228
TENSWave
K
22
2879
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K
21
2618
iRelieve Microcurrent Pain Relief System
K
21
3802
StimOnTM Pain Relief System (GM2439)
K
22
0578
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
K
22
0503
TENS device-EmeTerm 2, Model: YF-ZTY-E2
K
20
2893
Transcutaneous Electrical Nerve Stimulator
K
20
2186
TrueRelief Device
K
21
0202
BioWaveGO RX
K
20
1458
Scrambler Therapy Technology (Model ST-5A)
K
20
2159
actiTENS
K
20
1431
OGYILI TENS/NMES Stimulator
K
18
1645
StimaWELL 120MTRS
K
19
1547
ReliefBand
K
18
2960
ReliefBand
K
18
2025
ClearUP Sinus Pain Relief
K
18
0943
BioWaveGO
K
17
2478
TENS device-EmeTerm, CinvStop
K
17
3233
ReliefBand 1.5
K
16
1091
STIMPOD NMS460 Nerve Stimulator
K
16
2663
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
K
16
0246
SimulCare II(TM)
K
15
3704
Strive
K
15
2676
FD TENS 2090, FD TENS 2095
K
15
2437
BiowaveHOME Neuromodulation Pain Therapy Device
K
14
3198
Synapse Transcutaneous Electrical Stimulation Device
K
14
2666
Scrambler Therapy MC-5 A Device
K
13
1513
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
K
13
3779
CP RELIEF WAND
K
12
3099
Best-AV2 Pro-Sport(tm)
K
13
1675
BODIHEALTH SYSTEM
K
12
3958
JIAJIAN POINTOSELECT DIGITAL
K
13
0919
SENSUS
K
12
2948
GEM-STIM COMBO STIMULATOR
K
12
1369
NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
K
12
1305
STERLING MEDICAL IMPULSE 3 STIMULATOR
K
12
0398
WITOUCH PRO
K
12
1184
SENSUS
K
12
1578
ATOM 1 (MODEL: BRC 2200)
K
11
3544
ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
K
12
0569
GEMORE TENS SYSTEM
K
12
0054
ULTIMA NEO
K
11
2288
JIAJIAN TENS
K
11
1654
FD TENS 2070
K
11
2258
NEUROTECH PLUS
K
11
2485
H-WAVE
K
11
1645
FD TENS 2050 OR SLIDE TENS MODEL FD2050
K
10
2278
QUADRA BLOC TENS PLUS
K
11
0350
KNEEHAB XP
K
11
0390
ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
K
10
0668
NEMA-ST, MODEL V1.0.2
K
10
2014
TENS STIMULATOR, MODELS 2800 AND 3000
K
10
0399
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
K
09
2448
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
K
09
1045
SMART TENS, MODEL: D-BC05T
K
09
2990
AMD 6605 TENS/NMES
K
09
0866
NEUROCALM MODEL 1 AND 2
K
08
3250
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
K
09
1236
MANTRA COMBO, MODEL MECS 320
K
09
1317
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
K
09
0922
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
K
09
0717
FLEX-TENS
K
08
3822
LASER TOUCHONE
K
08
1835
ACTICARE IC AND TSE
K
08
2190
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298
K
08
2057
DX6605E-TENS, DX6605E-G, DX6609-G
K
08
1255
SCRAMBLER ST 5 TENS DEVICE
K
08
2377
TENSCARE ITOUCH MODEL(S) EASY AND PLUS
K
08
3030
TENS-EMS-14
K
08
3494
ULTIMA FIVE
K
08
3202
COMBOCARE 2000
K
08
2011
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
K
08
2514
TENS/EMS COMBO, EMS, TENS
K
08
0221
EA STIMULATOR
K
08
1141
COMBOCARE 2000
K
08
0304
PRO TENS, MODEL WL-240 RX
K
07
1120
AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999
K
07
3008
KFH ENERGY, MODEL: E1
K
07
1869
TENS/IF 14
K
07
3438
PROSTIM 1000/2000
K
07
2123
HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
K
07
1878
DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB
K
07
1624
EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR
K
06
2003
NEURO WAVE 6
K
07
1951
COMFY SERIES: EV-804, EV-805 & EV-806
K
06
1828
LORENZ BIOTECH APTIVA, VERSION 2.13
K
07
0299
EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)
K
06
2616
WELLNESSPRO 2010
K
06
2641
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
K
07
0474
NEWLIFE SCIENCES LLC, MODEL TMR
K
06
2547
QUADRA BLOC TENS, MODEL 101
K
05
2836
BODIHEALTH SYSTEM
K
06
1516
STAODYN MAX PRESET, MODEL 4470
K
06
1650
SELECT TENS, MODEL 4600S
K
06
0669
MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300
K
06
1799
QUADRATENS, MODEL QT-42
K
06
1476
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
K
05
2711
EMJOI TENS DEVICE
K
06
0517
POINTER EXCEL
K
06
0508
POINTER PLUS
K
06
0246
INFREX
K
05
0989
AWQ-104
K
06
0368
INSPIRSTAR IS02 MICROCURRENT STIMULATOR
K
05
3284
MAGBODY DT-600
K
05
1128
ELECTROPULSE
K
05
1020
ES-160
K
05
2813
FD TENS 2030, MODEL DFJ24T
K
05
2182
SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
K
05
0174
BIO-STIM KIT
K
05
0435
E-STIM II
K
04
2912
INTERX5000
K
05
0740
MICROWARE 200
K
04
2711
MODEL BMLS03-7
K
04
2107
TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001
K
04
1388
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
K
04
1172
BASBA E-MACHINE
K
04
2559
GEM-TWIN TENS/ MODELS GM3XY/Z
K
04
0311
SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331
K
04
1520
MANTRA TENS MODEL NT3
K
04
1359
BODY CLOCK STIMPLUS AND STIMPLUS PRO
K
04
1575
FENZIAN TREATMENT SYSTEM
K
04
1092
FAST START TENS, MODEL FS 3001
K
04
0512
LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
K
04
1164
L-TENS
K
04
0193
MODEL GST-1
K
02
3916
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
K
04
0253
EASY MED TN-28 C
K
03
3455
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K
03
2003
PREMIER PLUS
K
03
3857
T-TECH DIGITAL, MODEL WL-22XXA SERIES
K
03
2928
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
K
03
2994
GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)
K
03
2720
GEM-STIM TENS, MODELS GM3XY AND GM3AXY
K
03
1374
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660
K
03
1546
RAINBOW GT-4A PAIN RELIEF MACHINE
K
03
3253
S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K
03
2055
MEDS-4-INF+
K
03
2653
E275
K
02
3913
NEUROTECH BAXOLVE TYPE 294
K
02
3726
TENS PRO 900
K
02
2849
BODY CLOCK TENS N' TONE
K
02
1952
HIVOX DREAMATE DM-800
K
02
2417
CARE STIM
K
02
3231
ELFCARE DEVICE, MODELS 314A THROUGH 314G
K
03
0537
DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B
K
03
0140
DUOMED, SERIES 500, (MODELS ID 500, FL 500)
K
02
1271
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3
K
02
1270
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2
K
02
3443
MEDS-3 NEUROMUSCULAR STIMULATOR
K
02
3435
MEDS-4 NEUROMUSCULAR STIMULATOR
K
02
1794
TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING)
K
02
0020
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
K
02
1430
SANIDAD TENS-DUO MODE GP8016N
K
02
1846
804SIII; 804W; LIBRA TENS; 410; S-TENS II
K
02
2925
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
K
02
2841
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
K
02
2731
V TENS PLUS
K
02
0749
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
K
02
2076
FIRST CHOICE & FIRST CHOICE PLUS
K
02
0712
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
K
01
3532
ULTRASTIM KIT
K
02
2405
MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC
K
02
1496
HMS-DHR-3 NEUROMUSCULAR STIMULATOR
K
02
1436
TTECH MODEL 200E + TENS DEVICE
K
01
1891
PANAG
K
01
4020
NT MEDITENS PLUS, TYPE 290
K
02
1755
APEX MEDICAL DIGITAL TENS TS1211, TS1212
K
02
0803
CEFAR MEDICAL AB CEFAR PRIMO
K
02
0846
ULTIMA TENS XL-A1
K
01
4126
SANIDAD HEALTH-UP TENS MP-73725
K
02
1359
DIGI-PRO TENS MODEL WL-2203 AND WL-2205
K
01
3210
TRUWAVE
K
02
0180
RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL
K
02
0437
CLASSIC TENS
K
00
3744
ENRAF-NONIUS ENDOMED 182 SYSTEM
K
02
0032
APEX MEDICAL MINI TENS
K
01
3167
MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500
K
01
3507
COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
K
00
4008
STRESS GUARD, MODEL HERDEV1
K
01
2643
APEX MEDICAL LCD TENS-VII
K
01
2848
WINNER CM4 COMBINATION UNIT
K
01
0615
CYCLOTEC AMT CTI TENS DEVICE
K
01
1017
PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT
K
01
1543
TENS CARE, MODEL XL-Y3
K
01
0203
ACCU-PULSE TENS UNIT
K
01
0295
MICROSTIM 100I TENS DEVICE
K
00
2874
WELL-TENS
K
01
0209
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
K
00
1897
MULTI-STIM, MODEL MS-100
K
01
0782
TRANSAMERICAN TENS
K
00
2297
YORAMED, MODEL T-202
K
00
3369
LIFECARE COMPACT TENS DEVICE
K
00
3507
MEDRELIEF
K
00
3591
TENSCARE, MODEL TENS XL-2
K
99
3229
ANALGESIC PULSER, MODEL AP-439
K
00
3487
STIMATE N601 TENS
K
00
3258
MS-ONE, MODEL MS-1
K
00
3231
HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3
K
99
4266
FDTENS 2010
K
99
4265
MEDISANA DIGITAL TENS
K
98
4376
ENDOR 2000
K
99
4387
RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
K
99
1397
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
K
98
3907
RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
K
99
3823
MED-4000
K
99
2709
1818 TENS UNIT
K
99
0230
ELECTRO-NERVE STIMULATOR TENS, MODEL LX
K
98
2961
MEDIPOINT
K
98
2173
BUZBEE
K
98
2967
RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R
K
98
4025
CARE TENS
K
98
2324
VECTRA PRO MODELS 2 AND 4
K
98
2321
VECTRA STIM MODELS 200 AND 400
K
98
1976
ACUTRON MENTOR MODEL 961
K
98
2410
SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE
K
98
2436
RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R
K
98
2221
PREMIER AP
K
96
4437
GB-1002 TENS WITH MASSAGE
K
97
3979
MULTI-STIM TENS, AP-101081T
K
97
3978
MICRO II MICROCURRENT TENS
K
97
3980
ACU-STIM TENS, AP-101082T
K
97
2244
NT2000
K
98
0333
RELIEFBAND
K
97
4497
INTELECT
K
96
5244
Z TECH TRANSCUTANEOUS NEURAL STIMULATION
K
96
2951
MODEL HS-2 TENS DEVICE
K
96
5187
SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
K
96
1050
RELIEFBAND TENS UNIT (MODIFICATION)
K
94
0954
SYNAPTIC 3000
K
97
0429
BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
K
95
3982
SIMPLEX TENS
K
97
0203
EPIX VT
K
96
3507
EXTRA TENS (RI-2500) NEO TENS (RI-2000E)
K
97
0696
S.P. 100
K
96
1809
SHE-LI TENS STIMULATOR MODEL SL-101 RX
K
96
3729
SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
K
96
3125
M AND R REUSABLE ELECTRODES (MULTIPLE)
K
95
5470
ACTION POTENTIAL SIMULATION THERAPY DEVICE
K
96
1376
SMART-TENS, MODEL 456
K
96
2910
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
K
96
2332
TENS/FES/NMES ELECTRODES
K
96
1749
TRANSAMERICA ELECTRODE
K
95
4951
TAYLOR GENERAL PURPOSE MONITORING ELECTRODE
K
95
1951
FOCUS MODEL 795 UNIT
K
96
0969
GALVA 5-T
K
95
1903
EPIX XL TENS UNIT
K
95
4334
ACUPLUS
K
94
6230
ENDURA REUSABLE TENS AND NMES ELECTRODES
K
94
2631
ELECTROCARE
K
94
0600
STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ
K
94
6299
PGS123 AND HVS-123
K
94
1923
STERILE TREATMENT ELECTRODE
K
93
3197
THE SIGNATURE SERIES, M IV
K
94
4280
TRANSAMERICAN CLASSIC TENS
K
94
5676
GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES
K
93
3237
MEDI-STIM, MODIFICATION
K
93
4051
BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
K
93
2897
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K
93
1079
STAT-TENS
K
93
3368
TENS-IT
K
93
5324
THERAPEUTIC ULTRASOUND AND STIMULATOR
K
93
5395
NEURON II AND MICROTENS
K
93
0102
PULSATOR 5000
K
93
2592
BRACE NEUTRALIZER
K
93
5132
HOME MICROCURRENT HMC
K
93
4619
FLEXMATE
K
93
2854
EZ GRIP DISPOSABLE ELECTRODES
K
93
1108
EZ GRIP REUSABLE TENS/NMES ELECTRODES
K
93
2611
NEUROMUSCULAR STIMULATOR
K
93
2849
PMI TENS ELECTRODE
K
93
1715
PURECARE AT-903 T.E.N.S.
K
93
2320
NEUTRALIZER
K
93
1570
COM-TENS (SINGLE MODE)
K
93
1424
MAXIMA I
K
92
6326
MICROCARE(TM)
K
92
3970
INTEGRITY 2
K
92
2202
K-STIM CLEAR
K
93
0865
STAODYN MAXIMA III
K
92
5821
COMFORTRON
K
91
5663
TENS PRO 900
K
92
5686
THERA PULSE A ELECTRO NERVE STIMULATOR
K
92
5898
MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS
K
92
5729
SD-602 SD MODE 11, SD-603 SD MOD 111
K
92
0266
TENS MODEL 240Z
K
92
4545
MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR
K
92
3934
TX-3 SD
K
92
3935
SD-605 SD II PROGRAM
K
92
3298
MICRO 100,200,300, & 400 TENS
K
92
2690
PAIN-EEZ
K
92
0260
INTELECT 600MP
K
92
1679
K-DISPERSE
K
92
3255
Q-SD
K
92
1828
TEAM-MC II
K
92
1813
MED-TENS
K
92
1110
TENS
K
91
5210
ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A
K
91
2381
LOW BACK STRIP (OR) K-BACK
K
91
0727
EXCEL MODEL 2110
K
91
4813
THERASTIM
K
91
4871
TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
K
91
4441
MENS 2000-D
K
91
1963
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K
91
3532
TX 3 TENS MODIFIED
K
91
2289
ULTIMA XS, MODIFICATION
K
90
1704
RELIEF BAND (T.E.N.S. DEVICE)
K
91
2463
MICRO-Q
K
91
2460
Q-TENS
K
91
2178
BIO TENS 601, 606 AND 608 (3000)
K
91
1814
AXION 5, MODIFICATION
K
90
5672
TEAM-MC
K
91
3800
MEDA CROWN SERIES
K
91
3522
SOLITENS MODIFIED
K
91
3594
DYNEX IIIB, MODEL 89002026
K
91
0244
GLOBAL CARE MICRO II
K
91
2348
SX90 (TM),MODEL 4800S
K
90
5526
AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR
K
91
0580
MICROSTIM 100 MODEL 2C
K
90
2226
MY-O-MATIC 5000I
K
90
5570
ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A
K
90
5377
ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A
K
90
5230
ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A
K
90
4388
POINTER F-3 TENS
K
90
2102
COM-TENS: A NEUROSTIMULATOR
K
90
4288
MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS
K
90
4260
MENS-O-MATIC 3000
K
90
4258
MICRO DERM
K
90
4234
MENS-O-MATIC I
K
90
4430
MENS FREEDOM MICRO
K
90
4235
MENS-O-MATIC 2000
K
90
4264
MODEL SW-103 SOLITANS STIMULATOR
K
90
3394
GLOBALCARE MICRO 11 AND MICROCARE (TENS)
K
90
4457
DIAL-AWAY PAIN
K
90
3161
MC II (TM), MODEL 7200S
K
90
3577
DYNATRON 200 MICROCURRENT
K
90
3828
SYNAPS (TM)
K
90
3128
STIMTRAC PC, CATALOG NO. 78-8510
K
90
2822
MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE
K
89
6825
TRANSCUTANEOUS ELECTRONIC NERVE STIMULATOR
K
90
3017
MEGA-TENS DUAL CHANNEL T.E.N.S.
K
89
6408
QUANTUM
K
90
1417
ELECTROSTIM MST
K
90
1726
LUMISCOPE MICRO 100
K
89
6787
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION
K
90
0668
ACUDATA INDICATENS MODEL 5XS
K
90
0596
ACUDATA INDICATENS MODEL 5A
K
89
6620
NEUROTENS
K
89
6226
LISS BODY STIMULATOR MODEL SBL501-M
K
89
6948
ALPHA-STIM CS
K
88
3911
ELECTRO-ACUSCOPE 85
K
89
5289
MEC-I-TRON MINI, MODEL M-2
K
89
5183
REBOX II (TENS)
K
89
5977
ACUSOURCE 600 (TENS)
K
89
4964
K-2 TENS OR MED TENS
K
89
5473
DSX(TM), DIGITAL SX, QUANTUM DSX, MODEL 4700S
K
89
5295
ULTIMA XS MICROCURRENT TENS
K
89
5334
TTS2600
K
89
5161
TTS2800
K
89
5166
TTS2500
K
89
5211
TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K
88
3811
ELECTRONIC PAIN RELIEVERS
K
89
1992
TENZCARE STIMULATOR 6890
K
89
0087
ACUDATA INDICATENS MODEL 5M
K
89
4127
LUMISCOPE MODEL 1000/APCC MODEL 1000
K
89
1118
STERLING TENS
K
89
4388
ZIMMER TENS
K
88
4972
TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
K
89
2408
NSD 8CS8 - TENS DEVICE
K
88
4869
MODIFIED MRL NEUROPROBE SYSTEM V
K
89
0604
EMPI, MODEL 489, TENS
K
89
0088
ACUDATA INDICATENS MODEL 5X
K
88
5190
MICRO-STIM 200
K
88
2980
REBUILDER BUCKET SYSTEM
K
89
0705
MEDIMOD(TM), MODEL 8900
K
88
4833
ULTRA 2000 (T.E.N.S.)
K
88
0744
ANESTY 10
K
88
3188
T.E.N.S. UNIT SIGMA & TX-3
K
88
4210
TX-7 (TENS) (IC-1107)
K
88
3236
CEFAR DUAL
K
88
4032
MORGAN TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K
88
2154
HEPAX (TENS)
K
87
4818
TENSTAR
K
88
2631
EMPI MODEL 727,NMS
K
87
5072
MODIFIED AMANA ELECTROTHERAPEUTIC SYSTEM
K
88
0426
ELECTROSTIMULATOR MODEL 808
K
88
1753
ALPHA-STIM 350
K
88
2820
MEDIPAC II EC (TM), MODEL 7900
K
88
2943
MEDA ONE-STEP
K
88
1708
INDICATENS 4X4
K
88
0042
ACUTRON
K
88
1832
DS-200 AND DS-400 T.E.N.S.
K
88
1704
EASY TENS
K
88
0492
INTERCEPT T.E.N.S. DEVICE
K
88
1114
EMPI MODEL 989, TENS
K
88
1424
PREMIER 10S (TENS)
K
88
0980
SCHULDT* PC* - DUAL CHANNEL TENS
K
88
0751
ULTIMA XS (TENS)
K
88
0452
LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE
K
87
2704
AMASTIM 2000
K
87
3190
MEC-I-TRON, MODEL P-1
K
87
4085
REBUILDER(TM)
K
87
4550
TX-4(TENS) (SIGMA TENS)
K
87
4333
TX-2(TENS)
K
87
3357
ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA.
K
87
3420
GLOBALCARE(TENS)
K
87
3484
120Z(TENS)
K
87
2657
ULTRAPAC II SX PLUS (TM)
K
87
2398
T.E.N.S. DEVICE MODEL SPL 2000
K
87
2399
T.E.N.S. DEVICE MODEL SPL 2000S
K
87
1722
MEDTENS(TM), MODEL NUMBER 7725
K
87
1699
TX-3(TENS)
K
87
1666
MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR
K
87
1396
ACCULATOR 287EP
K
87
1125
ELECTRO-NERVE STIMULATOR TENS MODEL B5/SKN
K
87
1126
ELECTRO-NERVE STIMULATOR TENS MODEL C & B11, B11C
K
87
0667
OMEGA T200
K
87
0666
OMEGA T100
K
86
4370
DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)
K
87
0168
EMPI LOGIX MODEL 712 NMS, TENS
K
86
4114
TENS DEVICE FOR RELIEF OF CHRONIC PAIN
K
86
2454
AGAR 7K TENS INSTRUMENT
K
87
0583
NEU-PULS(TENS) MODEL #295
K
86
5063
UNI-PULS(TENS) MODEL #292
K
86
4968
BACPAC (TM), MODEL 6500
K
86
4956
DYNEX III TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
K
86
5048
ECLIPSE+, MODEL NUMBER 7723
K
86
4368
SCHULDT* PLUS 8 T.E.N.S. DEVICE
K
86
4735
A-TENS - MODEL AI-87
K
86
3469
CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA.
K
86
2352
ACCULATOR 487E
K
86
2602
AXION IV GOLDLINE SERIES
K
86
2450
MEDA 2500 T.E.N.S.
K
86
3567
'TENSAID'
K
86
3568
'MYOSTIM EX'
K
86
1896
UNI-TENS XL TENS
K
86
1895
UNI-TENS
K
86
1894
AGAR 9K TENS
K
86
2355
TRANS-PULSE MODEL #1103
K
86
2337
ULTRAPAC II SD (TM)
K
86
1119
WALLANT NEUROLOGIX DUAL PUR NERVE/NEUROMUSCU STIMU
K
86
0847
WALLANT NEUROLOGIX GENERAL PURPOSE TENS
K
85
2061
PULSAR NEUROSTIMULATOR
K
86
1830
EMPI MODEL GLS 450, TENS
K
86
1451
EMPI MODEL 720 NMS, TENS
K
86
1214
SKYLARK GB 1000
K
85
3898
SKYLARK MODEL 1001 TENS DEVICE
K
86
1709
A TENS (MODEL AI-86)
K
86
0772
HARIKY, MODEL GK-7
K
86
1501
EXER-STIM 2
K
85
4316
FASTENS(TM)
K
85
4476
KALMATE MODEL 3A
K
85
3992
VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
K
85
4761
MINIPAC PERSONAL TOUCH (TM)
K
85
3885
MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA
K
85
4317
MINIPAC (TM)
K
85
0855
TENS GB1001 DEVICE
K
85
3836
NEURO PULSE II
K
85
3442
MODEL 804 (TENS)
K
85
3719
TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410
K
85
3718
TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804
K
85
1735
SYS STIM 206 MODEL ME206
K
85
3416
MES-TENS(TENS)
K
85
2838
ADVANCED MEDICAL PRODUCTS MES TENS
K
85
2837
ADVANCED MEDICAL PRODUCTS DR PULSE (TENS)
K
85
2836
ADVANCED MEDICAL PRODUCTS MINI-M (TENS)
K
84
4618
BIO-TENS
K
85
1511
ACCURATECARE I & ACCURATECARE II
K
85
1063
TENSMED II
K
85
1191
ELECTRO-NERVE STIMULATOR DISCO B9 TENS
K
85
0860
AXON II BRAND OF DUAL CHANNEL TENS
K
85
1185
ELECTRO-NERVE STIMULATOR B4/B400
K
84
4680
CYBERTENS
K
85
0004
TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF
K
84
4994
THE MEHESZ STIMULATING SYSTEM
K
84
1427
ACCU-O-MATIC
K
84
4279
INTERCEPTOR, 662-01
K
84
4076
ELECTRO-NERVE STIMULATOR B5/SK700B
K
84
2888
DUAL CHANNEL TENS, PULSAR REMOTE CONTRL
K
84
4212
STIMTECH SD CLINICIAN 6090 #78-8055
K
84
4213
STIMTECH SD PATIENT 6089 #78-8050
K
84
4638
ELECTROCAINE MODEL SR-IV
K
84
3637
HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI
K
84
0099
MODEL 800-A VERI/PPR
K
84
3822
MEA110
K
84
3793
A-T TENS BELT
K
84
1184
ELECTRO-NERVE STIMULATOR HL
K
84
3119
ETI TENS BELT
K
84
2812
MENTOR 150 PLUS TRANSCUTANEOUS ELEC.
K
84
2414
ECHO PULSE BURST
K
84
0098
MODEL 811 VERI/TENS & PO
K
84
1400
NEURO PULSE
K
84
0964
SD PLUS CLINICIAN CAT# 78-8015
K
84
0963
SD PLUS PATIENT CAT.#78-8010
K
84
0497
OBSTETRIC PULSAR TWO CHANNEL TENS
K
84
1045
EMPI MODEL 984 BASIX, TENS
K
84
1000
BET MODEL 1010
K
84
0599
MULTI-STIMT
K
84
0821
TRNS MI 8202
K
83
3251
MODEL MK II TENS
K
83
4334
MEDAID DUAL CHANNEL TENS
K
84
0040
HEALTH-UP
K
83
3086
NEUROTRON 100
K
83
4215
MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM
K
83
1938
TRANSCUTANEOUS ELECTRONIC NERVE STIMU
K
83
3037
POINTER F-3
K
83
3354
AUTO-TENS MODEL VI DUAL CHANNEL BATT
K
83
1990
NEUROFLAX, EPK
K
83
2160
ELECTRO-PULSE
K
83
2442
ELECTRO-ACUSCOPE
K
83
2851
AGAR 8000 TENS
K
83
1487
ELECTRONEURAL STIMULATOR 12
K
83
2337
AUTO-TENS MODEL V
K
83
2238
NEUROMOD COMFORT WAVE #7721 DUAL-
K
83
0992
XCEL MODEL XE-1
K
83
1950
PULSAR #B SINGLE CHANNEL TENS-PULSAR D
K
83
1850
NEURO-PULSER 2 TRANSCUTAN. ELEC. NERVE
K
83
1147
OMNIPROBE ELECTRICAL NERVE STIMULATOR
K
83
1145
ALPHA-STIM 350
K
83
1144
ALPHA-STIM 2000
K
83
1413
SPEC IISX
K
83
0747
PC 2909A-HEALTH PULSE CONTROL STIMULATOR
K
83
0932
NYNEX II
K
83
0792
PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE
K
82
3466
AUTO-TENS MODEL III DUAL CHANNEL REPLACE
K
82
3467
AUTO-TENS MODEL I DISPOS. SINGLE CHAN
K
82
3465
AUTO-TENS MODEL II SINGLE CHANNEL
K
82
3464
AUTO-TENS MODEL IV -DUAL CHANNEL FULL
K
82
3742
NEUROMOD COMPLEMENT #7724 DUAL CHANNEL
K
82
3497
WRIGHT CARE
K
82
3299
MODEL 402P SEQUENCER FOR EMPI TEMS DEV
K
82
3002
DENDRITE VM-TRANSCUTANEOUS ELEC. NERVE
K
82
2929
VERIL/PPR PERSONAL PAIN RELIEVER #800
K
82
2841
THE EMD TENZ PAIN CONTROL SYSTEM
K
82
2854
PRO MED 100
K
82
2600
NEUROMEDICS ORIONS #660-01
K
82
1571
TP440 ORTHOPROBE
K
82
1523
OMNI TENS
K
82
1363
TRANS-Q
K
82
0651
MODEL 860-1 VERI/PROBE
K
82
0326
BIGSTON TRANSCUTANEOUS NERVE STIMULAT
K
82
0678
SYSTEM 10
K
81
3601
E.W.L. P-TENS MODEL(TENS
K
82
0496
TENS MODEL 8201
K
81
3569
EMOTENS
K
81
2612
TNS MK I STIMULATOR
K
81
3283
10D (TENS DEVICE)
K
81
3501
TRANSCUTANEOUS ELEC. NERVE STIMULATOR
K
81
3100
BIO-STIMULATOR, MODEL 400
K
81
2432
HEALTH-UP
K
81
2704
NEUROMED SELECTRA #7720
K
81
2138
TENS DEVICE
K
81
1499
TENSMAX
K
81
2036
NEUROGAR III
K
81
1351
VERI-FIER
K
81
1939
VITATRON 88
K
81
1345
INSIGHT
K
81
1095
TRANSCUTANEOUS ELECTRICAL NERVE
K
81
0841
MEDAID
K
81
1224
MINISTIM
K
81
1012
TENS-O-MATIC
K
81
0593
NEUROPAC ULTRA I
K
80
3121
MENTOR 150 TRANSCUTANEOUS NERVE STIMULA
K
80
3113
MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT
K
80
2779
LOAD SENTINEL II, TRANS. ELEC. NERVE
K
80
2678
TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR
K
80
2507
TENSMATE EMPIMODEL 9980
K
80
2063
SPEMBLY 9000 & 9300
K
80
2227
ANASTIM II TRANSCUTANEOUS ELECTRICAL
K
80
1459
ELECTRO-ACUSCOPE-70
K
80
1576
NEUROGAR III-TRANSCUT. ELEC. NERVE STIM
K
80
0576
CYCLOPAC CP100 TENS BANDAGE
K
80
1112
EMPI MODEL 910S, TENS
K
80
0758
TENZCARE DUAL-CHANNEL STIMULATOR
K
80
0630
TYPE 4000 TRANSCUTANEOUS ELEC. STIM.
K
79
2473
THERAPETTE, MODEL NO MH-100
K
79
2502
TENS 4100
K
79
2522
MODEL 980D TENS NEUROPACER
K
79
2474
TENS 4500
K
79
2311
MEDTRONIC MODEL 7728 NEUROMOD
K
79
1834
NURITE II VRM DUAL (ELEC. NERVE STIM.)
K
79
1833
NURITE II VRM SINGLE (ELEC. NERVE STIM)
K
79
1187
MODEL 810 VERI/TGS
K
79
1158
STIMULATOR, ELECTRICAL NERVE
K
78
2164
STIMULATOR, MODEL 1-600 ELECTRIC NERVR
K
79
0011
STIMULATOR, MENTOR 100 NERVE
K
79
0189
ELECTREAT MODEL 250 TRANSCUTANEOUS STIM
K
78
2127
STIMULATOR, ELECTRICAL NERVE
K
78
2075
STIMULATOR, MODEL 7727
K
78
1829
NEUROPAC ULTRA II
K
78
1670
STIMULATOR, E.S.I. NEURO
K
78
1683
NURITE II, SINGLE
K
78
1565
ELECTRICAL NERVE STIMULATOR MODEL 6035
K
78
1277
STIMULATOR, NERVE, TRANSCUTANEOUS
K
78
0828
NURITE II
K
78
0698
STIMULATORS, NERVE, ELECTRICAL
K
78
0444
NERVTRON-RX
K
78
0186
NEUROMOD STIMULATOR MODEL 3723
K
77
2224
NERVE STIMULATOR, ELEC. TRANSCUTANEOUS
K
77
1885
IMPORTED PAIN CONTROL DEVICE
K
77
1122
VERI/CTGS MODEL 850
K
76
1053
ANODYNE II-ELECTRICAL NEURO STIMULATOR
HAX
Tong, Skull For Traction
HBP
Clip, Implanted Malleable
HBW
Fastener, Plate, Cranioplasty
HBZ
Catheter, Intravascular Occluding
HCB
Device, Aversive Conditioning
HCC
Device, Biofeedback
HCE
Clamp, Carotid Artery
HCG
Device, Neurovascular Embolization
HCH
Clip, Aneurysm
JXG
Shunt, Central Nervous System And Components
JXH
Methyl Methacrylate For Aneurysmorrhaphy
JXI
Cuff, Nerve
JXK
Cranial Electrotherapy Stimulator To Treat Depression
JXL
Block, Bite
LEL
Device, Sleep Assessment
LHG
Electrode, Spinal Epidural
LIH
Interferential Current Therapy
MVA
Orthosis, Cranial
MYU
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
MZQ
Balloon, Detachable, For Neurovascular Occlusion
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
NHI
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
NUF
Catheter, Neurovasculature, Occluding Balloon
NUH
Stimulator, Nerve, Transcutaneous, Over-The-Counter
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
NYW
Stimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief
NYX
Stimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes
OAN
Orthosis, Cranial, Laser Scan
OBP
Transcranial Magnetic Stimulator
OBV
Eating Disorder Conditioning Tool
OCF
Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
QMD
Transcranial Magnetic Stimulation System For Smoking Cessation
OSG
Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
PAV
Catheter, Neuro-Vasculature, Occluding Balloon
PBJ
Cranial Distraction System
PCB
External Cerebrospinal Fluid (Csf) Diversion
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
PJM
Filler, Bone Void, Alterable Compound For Cranioplasty
PJN
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
PKR
Non-Invasive Vagus Nerve Stimulator - Headache
PLU
Thermal System For Insomnia
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
PUU
Temporary Coil Embolization Assist Device
PVL
Endoscopic Shunt Placement Kit
PVO
Lumbar Drainage Catheter Kit
PWE
Computerized Behavioral Therapy Device For Psychiatric Disorders
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
QAK
Non-Invasive Vagus Nerve Stimulator For Migraine Headache
QAR
Thermal Vestibular Stimulator For Headache
QBC
External Upper Limb Tremor Stimulator
QCI
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
QFD
Tens For Sinus Pain
QFF
Electromechanical Arm For A Transcranial Magnetic Stimulation System
QGH
Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
QGL
Transcutaneous Nerve Stimulator For Adhd
QGT
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
QMZ
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
QQC
Brain Stimulation Programming Planning Software.
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
OVP
Vibratory Counter-Stimulation
QVO
Computerized Behavioral Therapy Device For Insomnia
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-f—neurological-therapeutic-devices
/
GZJ
/
K180943
View Source
BioWaveGO
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180943
510(k) Type
Traditional
Applicant
Biowave Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/17/2018
Days to Decision
129 days
Submission Type
Summary