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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
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
K
24
3334
Nooro Body & Foot Stimulator (SM9141, SM9142)
2
Cleared 510(K)
K
24
2332
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
2
Cleared 510(K)
K
24
2567
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
2
Cleared 510(K)
K
23
3054
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
2
Cleared 510(K)
K
24
1678
TENS & EMS Stimulator (MHD-1083)
2
Cleared 510(K)
K
24
1365
Pixie Pulse (SM9068)
2
Cleared 510(K)
K
24
1119
Transcutaneous Electrical Nerve Stimulator (K6106)
2
Cleared 510(K)
K
23
3067
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
2
Cleared 510(K)
K
24
1509
TENS&EMS units (SM9109A, SM9109B)
2
Cleared 510(K)
K
23
3046
Electrical Neuromuscular Stimulator, Cure Trio
2
Cleared 510(K)
K
23
1425
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
2
Cleared 510(K)
K
24
0292
Transcutaneous Electrical Nerve Stimulator (9029SCM)
2
Cleared 510(K)
K
23
2439
Electrical Stimulator System
2
Cleared 510(K)
K
23
3095
S21 OTC Transcutaneous Electrical Nerve Stimulator
2
Cleared 510(K)
K
23
1648
Muscle Stimulator
2
Cleared 510(K)
K
23
3784
ENSO (Model 2)
2
Cleared 510(K)
K
23
3092
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
2
Cleared 510(K)
K
23
3040
EMS/TENS Massager Device
2
Cleared 510(K)
K
23
1423
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
2
Cleared 510(K)
K
23
3461
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
2
Cleared 510(K)
K
23
0926
Ova+ (K-OVAP-USA)
2
Cleared 510(K)
K
23
2517
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
2
Cleared 510(K)
K
23
1569
ManaFlexx 2 (model: MF002-RX, MF002-OTC)
2
Cleared 510(K)
K
23
2675
Heating Tens, FT-615
2
Cleared 510(K)
K
23
1053
Unicare (K-UNICARE-USA)
2
Cleared 510(K)
K
22
3151
Nu-beca Transcutaneous Electrical Nerve Stimulation
2
Cleared 510(K)
K
23
0443
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
2
Cleared 510(K)
K
22
3308
HEATING TENS/EMS, FT-810R
2
Cleared 510(K)
K
22
2870
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
2
Cleared 510(K)
K
22
3825
Tens & Ems Device
2
Cleared 510(K)
K
22
3428
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
2
Cleared 510(K)
K
23
0829
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
2
Cleared 510(K)
K
23
0164
TENS and EMS Stimulation (OTC)
2
Cleared 510(K)
K
23
0163
TENS and EMS Stimulation (OTC)
2
Cleared 510(K)
K
23
0174
TENS and EMS Stimulation (OTC)
2
Cleared 510(K)
K
22
2867
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
2
Cleared 510(K)
K
22
2488
Everyway Analog OTC TENS
2
Cleared 510(K)
K
22
1992
Electronic Pulse Stimulator
2
Cleared 510(K)
K
22
1092
Transcutaneous Electrical Nerve Stimulator Model: ST-304
2
Cleared 510(K)
K
22
0997
Wireless TENS/EMS, Bruno, Aela
2
Cleared 510(K)
K
22
0998
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
2
Cleared 510(K)
K
22
0524
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
2
Cleared 510(K)
K
22
1251
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
2
Cleared 510(K)
K
22
0573
Noodle
2
Cleared 510(K)
K
22
1384
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
2
Cleared 510(K)
K
21
3788
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
2
Cleared 510(K)
K
22
0283
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
2
Cleared 510(K)
K
22
0152
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
2
Cleared 510(K)
K
21
2377
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
2
Cleared 510(K)
K
22
0005
TENS & PMS Unit
2
Cleared 510(K)
K
21
2184
TENS and EMS Stimulation (OTC)
2
Cleared 510(K)
K
21
3741
TENS & EMS DEVICE (Model: FM-B2403A)
2
Cleared 510(K)
K
21
3835
TENS & EMS Device
2
Cleared 510(K)
K
21
3091
Well-Life TENS/EMS/Heating Stimulator
2
Cleared 510(K)
K
22
0150
TENS & PMS (Model: SM9126)
2
Cleared 510(K)
K
21
1263
Intrelief
2
Cleared 510(K)
K
21
2285
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
2
Cleared 510(K)
K
21
0223
Transcutaneous Electrical Nerve Stimulator
2
Cleared 510(K)
K
21
2918
Heat StimPlus
2
Cleared 510(K)
K
21
2989
Low-frequency Stimulator (Model: AST-645, AST-646)
2
Cleared 510(K)
K
20
2671
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
2
Cleared 510(K)
K
21
1403
HIVOX OTC Electrical Stimulator, FT610-B
2
Cleared 510(K)
K
20
0558
Smart Neck Stimulator
2
Cleared 510(K)
K
21
1736
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
2
Cleared 510(K)
K
21
0756
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
2
Cleared 510(K)
K
20
0694
Perfect EMS
2
Cleared 510(K)
K
20
2866
TENS & EMS Device
2
Cleared 510(K)
K
20
0177
Low-frequency Multi-function physiotherapy instrument
2
Cleared 510(K)
K
20
3574
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
2
Cleared 510(K)
K
20
2849
Everyway Analog OTC TENS, model N103A/N302
2
Cleared 510(K)
K
20
2470
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
2
Cleared 510(K)
K
20
2317
Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
2
Cleared 510(K)
K
20
1335
Li-Battery powered OTC TENS/EMS Combination Stimulator
2
Cleared 510(K)
K
20
0237
Transcutaneous Electronic Nerve Stimulator
2
Cleared 510(K)
K
19
1982
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
2
Cleared 510(K)
K
19
3655
MSLS6QF TENS/PMS Device
2
Cleared 510(K)
K
20
0838
Tyece OTC TENS Model
2
Cleared 510(K)
K
20
0561
StimPlus Patch, StimPlus Patch, StimPlus Patch
2
Cleared 510(K)
K
20
0354
Electronic stimulator
2
Cleared 510(K)
K
20
0727
TENS and Muscle Stimulator
2
Cleared 510(K)
K
19
2201
Electrical Stimulator System
2
Cleared 510(K)
K
18
3110
LIVIA
2
Cleared 510(K)
K
19
0783
Health Expert Electronic Stimulator (model: AST-3000L)
2
Cleared 510(K)
K
19
2589
Everyway OTC TENS/EMS Combination
2
Cleared 510(K)
K
19
0673
Health Expert Electronic Stimulator
2
Cleared 510(K)
K
19
0009
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
2
Cleared 510(K)
K
19
1075
Healy
2
Cleared 510(K)
K
19
2087
Combo Electrotherapy Device
2
Cleared 510(K)
K
18
3674
Electronic Pulse Stimulator
2
Cleared 510(K)
K
18
2136
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
2
Cleared 510(K)
K
18
2671
Medi-Direct TENS Pen
2
Cleared 510(K)
K
18
3215
Focus TENS Therapy, Model PM710-M/-L
2
Cleared 510(K)
K
19
0988
GIM-STIM OTC TENS/EMS System
2
Cleared 510(K)
K
18
2871
Mini TENS Therapy Device
2
Cleared 510(K)
K
18
3288
Transcutaneous Electrical Nerve Stimulator
2
Cleared 510(K)
K
19
1151
JKH Stimulator Plus
2
Cleared 510(K)
K
19
0115
MHD TENS
2
Cleared 510(K)
K
18
2108
Portable Electro-Stimulation Therapy Device
2
Cleared 510(K)
K
19
0347
HIVOX OTC Electrical Stimulator
2
Cleared 510(K)
K
18
2203
JKH Stimulator Plus
2
Cleared 510(K)
K
18
2267
PAT (Pain Alleviation Technologies)
2
Cleared 510(K)
K
18
2120
Maxpower Relief
2
Cleared 510(K)
K
17
2897
Neck Care Therapy, Model: SYK 509B
2
Cleared 510(K)
K
17
2837
Low-frequency Multi-function physiotherapy instrument
2
Cleared 510(K)
K
18
2581
PlayMakar Sport Muscle Stimulator, Model PRO-500
2
Cleared 510(K)
K
18
1992
Heat Pain Pro
2
Cleared 510(K)
K
18
2753
A6 OTC Pain Relief TENS
2
Cleared 510(K)
K
18
2767
V2 OTC Pain Relief TENS
2
Cleared 510(K)
K
18
1707
Everyway Wireless TENS & EMS Unit
2
Cleared 510(K)
K
18
1102
ThermaCare Quick Therapy TENS
2
Cleared 510(K)
K
17
2834
Dual output digital therapy massager
2
Cleared 510(K)
K
18
1849
iStim S2 OTC Pain Relief TENS
2
Cleared 510(K)
K
17
2971
BMLS16-1
2
Cleared 510(K)
K
18
0331
Wireless Pain Relieve Device
2
Cleared 510(K)
K
18
0956
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
2
Cleared 510(K)
K
18
1207
Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
2
Cleared 510(K)
K
17
2919
EV-804 OTC Pain Relief TENS
2
Cleared 510(K)
K
17
1802
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
2
Cleared 510(K)
K
17
3462
Wireless Pain Relieve Device Model: LT5018C
2
Cleared 510(K)
K
17
1803
HIVOX OTC Electrical Stimulator
2
Cleared 510(K)
K
17
2451
Dr.MUSIC 3s
2
Cleared 510(K)
K
17
1026
Mytens Model: BW-TSX
2
Cleared 510(K)
K
17
2079
Avail
2
Cleared 510(K)
K
17
2809
OTC Combo TENS/EMS System
2
Cleared 510(K)
K
17
1599
WiTouch Pro, WiTouch, Neubac
2
Cleared 510(K)
K
16
3611
Pain Therapy Device
2
Cleared 510(K)
K
16
3166
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
2
Cleared 510(K)
K
16
3393
Hi-Dow Wireless TENS/EMS System (Model HD-SN)
2
Cleared 510(K)
K
16
3153
Livia
2
Cleared 510(K)
K
17
0659
IQ Technologies
2
Cleared 510(K)
K
16
2392
Avazzia
2
Cleared 510(K)
K
17
0205
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
2
Cleared 510(K)
K
17
0145
Digital TENS Unit
2
Cleared 510(K)
K
16
2517
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
2
Cleared 510(K)
K
16
2479
Smart Pain Reliever, Model LT5019
2
Cleared 510(K)
K
16
2630
CP Relief Wand-OTC
2
Cleared 510(K)
K
16
1453
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
2
Cleared 510(K)
K
16
0508
Electronic Pulse Stimulator
2
Cleared 510(K)
K
16
1537
OTC TENS Device, Model PTS-IV
2
Cleared 510(K)
K
15
1995
Painmaster MCT Patch
2
Cleared 510(K)
K
16
0255
HBOTC Muscle and Nerve Stimulator
2
Cleared 510(K)
K
16
0893
HANAROCare ReJu
2
Cleared 510(K)
K
16
0115
Heat Pain Pro
2
Cleared 510(K)
K
16
0052
CUR Model 1
2
Cleared 510(K)
K
15
3520
Electronic Pulse Stimulator
2
Cleared 510(K)
K
15
0277
Pain Therapy System, Model PTS-II
2
Cleared 510(K)
K
15
2374
LL TENS 160A, LL TENS 160B
2
Cleared 510(K)
K
15
2954
Quell
2
Cleared 510(K)
K
15
2128
2-in-1 Abdominal Muscle Training & Back Pain Relief System
2
Cleared 510(K)
K
15
2852
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
2
Cleared 510(K)
K
15
1279
Counter OTC TENS Device, Model CSD-737Z
2
Cleared 510(K)
K
15
1034
PainKARE
2
Cleared 510(K)
K
15
0386
Tyece OTC TENS Device
2
Cleared 510(K)
K
15
0308
Palm TENS
2
Cleared 510(K)
K
15
1479
EV-820 OTC Pain Relief TENS
2
Cleared 510(K)
K
15
0043
Transcutaneous Electrical Nerve Stimulators (TENS)
2
Cleared 510(K)
K
15
1035
PulseRelief
2
Cleared 510(K)
K
14
3268
TENS AND POWERED MUSCLE STIMULATOR
2
Cleared 510(K)
K
15
0995
Electronic Pulse Stimulator
2
Cleared 510(K)
K
14
3430
SmartTENS
2
Cleared 510(K)
K
15
0681
GEMORE OTC TENS
2
Cleared 510(K)
K
13
3789
DOLPHIN NEUROSTIM OTC
2
Cleared 510(K)
K
14
2686
StimPad OTC
2
Cleared 510(K)
K
14
1978
MAXPOWER RELIEF
2
Cleared 510(K)
K
13
3502
5000Z FIREFLY SYSTEM
2
Cleared 510(K)
K
14
1299
OTC COMBO TENS/EMS SYSTEM
2
Cleared 510(K)
K
13
3929
HEALTH EXPERT ELCTRONIC STIMULATOR
2
Cleared 510(K)
K
14
1260
ELECTRONIC PULSE STIMULATOR
2
Cleared 510(K)
K
14
0168
EASYSTIM TN28_OTC
2
Cleared 510(K)
K
13
3979
TENS
2
Cleared 510(K)
K
13
1290
IQ TECHNOLOGIES
2
Cleared 510(K)
K
14
0333
ASCEND
2
Cleared 510(K)
K
14
0650
HIVOX ELECTRIC STIMULATOR OTC TENS
2
Cleared 510(K)
K
13
2993
COUNTER OTC TENS DEVICE
2
Cleared 510(K)
K
13
2563
PINOOK STIMULATOR
2
Cleared 510(K)
K
13
1956
QUICK RELAX PRO
2
Cleared 510(K)
K
13
3723
OTC PATCH
2
Cleared 510(K)
K
13
1910
MPP
2
Cleared 510(K)
K
13
1933
ELECTRONIC PULSE MASSAGER
2
Cleared 510(K)
K
13
1921
ELECTRONIC PULSE STIMULATOR
2
Cleared 510(K)
K
12
2410
I RUNE (I-200L)
2
Cleared 510(K)
K
13
0150
TCM MASSAGER
2
Cleared 510(K)
K
13
0802
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
2
Cleared 510(K)
K
12
3866
TANYX
2
Cleared 510(K)
K
13
1159
SMARTRELIEF
2
Cleared 510(K)
K
12
4055
T1040 AKA AURAWAVE
2
Cleared 510(K)
K
13
0114
PAINMASTER MCT PATCH
2
Cleared 510(K)
K
12
2744
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
2
Cleared 510(K)
K
12
1757
HEALTHMATEFOREVER
2
Cleared 510(K)
K
12
1353
MINI PATCH
2
Cleared 510(K)
K
11
3321
TENS BACK PAIN RELIEF SYSTEM
2
Cleared 510(K)
K
12
0500
THE PAIN PILOT (A.K.A PAIN PILOT)
2
Cleared 510(K)
K
11
2392
HIVOX BIOTEK INC.
2
Cleared 510(K)
K
11
3037
PAIN-AID
2
Cleared 510(K)
K
11
0068
MODEL PM3030
2
Cleared 510(K)
K
11
2415
LIFECARE ARM & LEG PAIN RELIEF SYSTEM
2
Cleared 510(K)
K
11
0716
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
2
Cleared 510(K)
K
11
0707
CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
2
Cleared 510(K)
K
10
2051
PAIN BUDDY
2
Cleared 510(K)
K
10
2598
HI-DOW-XP
2
Cleared 510(K)
K
10
0441
XINIWAVE, MODEL XW-18
2
Cleared 510(K)
K
10
0116
LASERTOUCHONE (OTC)
2
Cleared 510(K)
K
09
1757
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
2
Cleared 510(K)
K
09
0042
PAINMASTER MCT PATCH
2
Cleared 510(K)
K
06
0846
THERAPEUTIC MASSAGE COMPANION
2
Cleared 510(K)
K
06
3743
RHYTHM TOUCH Q 2-WAY
2
Cleared 510(K)
K
06
2532
ELECTROPULSE - LOW BACK PAIN
2
Cleared 510(K)
K
06
3660
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
2
Cleared 510(K)
K
06
0222
LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
2
Cleared 510(K)
K
05
2785
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
2
Cleared 510(K)
K
03
3122
5000Z SYSTEM (OTC)
2
Cleared 510(K)
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 6 December 2024 at 11:05 pm
NE
/
subpart-f—neurological-therapeutic-devices
/
NUH
/
K233784
View Source
ENSO (Model 2)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233784
510(k) Type
Traditional
Applicant
Hinge Health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/23/2024
Days to Decision
88 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
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
K
24
3334
Nooro Body & Foot Stimulator (SM9141, SM9142)
K
24
2332
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
K
24
2567
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
K
23
3054
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
K
24
1678
TENS & EMS Stimulator (MHD-1083)
K
24
1365
Pixie Pulse (SM9068)
K
24
1119
Transcutaneous Electrical Nerve Stimulator (K6106)
K
23
3067
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
K
24
1509
TENS&EMS units (SM9109A, SM9109B)
K
23
3046
Electrical Neuromuscular Stimulator, Cure Trio
K
23
1425
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
K
24
0292
Transcutaneous Electrical Nerve Stimulator (9029SCM)
K
23
2439
Electrical Stimulator System
K
23
3095
S21 OTC Transcutaneous Electrical Nerve Stimulator
K
23
1648
Muscle Stimulator
K
23
3784
ENSO (Model 2)
K
23
3092
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
K
23
3040
EMS/TENS Massager Device
K
23
1423
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
K
23
3461
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
K
23
0926
Ova+ (K-OVAP-USA)
K
23
2517
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
K
23
1569
ManaFlexx 2 (model: MF002-RX, MF002-OTC)
K
23
2675
Heating Tens, FT-615
K
23
1053
Unicare (K-UNICARE-USA)
K
22
3151
Nu-beca Transcutaneous Electrical Nerve Stimulation
K
23
0443
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
K
22
3308
HEATING TENS/EMS, FT-810R
K
22
2870
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
K
22
3825
Tens & Ems Device
K
22
3428
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
K
23
0829
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
K
23
0164
TENS and EMS Stimulation (OTC)
K
23
0163
TENS and EMS Stimulation (OTC)
K
23
0174
TENS and EMS Stimulation (OTC)
K
22
2867
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
K
22
2488
Everyway Analog OTC TENS
K
22
1992
Electronic Pulse Stimulator
K
22
1092
Transcutaneous Electrical Nerve Stimulator Model: ST-304
K
22
0997
Wireless TENS/EMS, Bruno, Aela
K
22
0998
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
K
22
0524
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
K
22
1251
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
K
22
0573
Noodle
K
22
1384
Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
K
21
3788
TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
K
22
0283
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
K
22
0152
TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
K
21
2377
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
K
22
0005
TENS & PMS Unit
K
21
2184
TENS and EMS Stimulation (OTC)
K
21
3741
TENS & EMS DEVICE (Model: FM-B2403A)
K
21
3835
TENS & EMS Device
K
21
3091
Well-Life TENS/EMS/Heating Stimulator
K
22
0150
TENS & PMS (Model: SM9126)
K
21
1263
Intrelief
K
21
2285
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
K
21
0223
Transcutaneous Electrical Nerve Stimulator
K
21
2918
Heat StimPlus
K
21
2989
Low-frequency Stimulator (Model: AST-645, AST-646)
K
20
2671
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
K
21
1403
HIVOX OTC Electrical Stimulator, FT610-B
K
20
0558
Smart Neck Stimulator
K
21
1736
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
K
21
0756
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
K
20
0694
Perfect EMS
K
20
2866
TENS & EMS Device
K
20
0177
Low-frequency Multi-function physiotherapy instrument
K
20
3574
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
K
20
2849
Everyway Analog OTC TENS, model N103A/N302
K
20
2470
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300
K
20
2317
Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
K
20
1335
Li-Battery powered OTC TENS/EMS Combination Stimulator
K
20
0237
Transcutaneous Electronic Nerve Stimulator
K
19
1982
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
K
19
3655
MSLS6QF TENS/PMS Device
K
20
0838
Tyece OTC TENS Model
K
20
0561
StimPlus Patch, StimPlus Patch, StimPlus Patch
K
20
0354
Electronic stimulator
K
20
0727
TENS and Muscle Stimulator
K
19
2201
Electrical Stimulator System
K
18
3110
LIVIA
K
19
0783
Health Expert Electronic Stimulator (model: AST-3000L)
K
19
2589
Everyway OTC TENS/EMS Combination
K
19
0673
Health Expert Electronic Stimulator
K
19
0009
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
K
19
1075
Healy
K
19
2087
Combo Electrotherapy Device
K
18
3674
Electronic Pulse Stimulator
K
18
2136
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
K
18
2671
Medi-Direct TENS Pen
K
18
3215
Focus TENS Therapy, Model PM710-M/-L
K
19
0988
GIM-STIM OTC TENS/EMS System
K
18
2871
Mini TENS Therapy Device
K
18
3288
Transcutaneous Electrical Nerve Stimulator
K
19
1151
JKH Stimulator Plus
K
19
0115
MHD TENS
K
18
2108
Portable Electro-Stimulation Therapy Device
K
19
0347
HIVOX OTC Electrical Stimulator
K
18
2203
JKH Stimulator Plus
K
18
2267
PAT (Pain Alleviation Technologies)
K
18
2120
Maxpower Relief
K
17
2897
Neck Care Therapy, Model: SYK 509B
K
17
2837
Low-frequency Multi-function physiotherapy instrument
K
18
2581
PlayMakar Sport Muscle Stimulator, Model PRO-500
K
18
1992
Heat Pain Pro
K
18
2753
A6 OTC Pain Relief TENS
K
18
2767
V2 OTC Pain Relief TENS
K
18
1707
Everyway Wireless TENS & EMS Unit
K
18
1102
ThermaCare Quick Therapy TENS
K
17
2834
Dual output digital therapy massager
K
18
1849
iStim S2 OTC Pain Relief TENS
K
17
2971
BMLS16-1
K
18
0331
Wireless Pain Relieve Device
K
18
0956
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
K
18
1207
Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
K
17
2919
EV-804 OTC Pain Relief TENS
K
17
1802
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K
17
3462
Wireless Pain Relieve Device Model: LT5018C
K
17
1803
HIVOX OTC Electrical Stimulator
K
17
2451
Dr.MUSIC 3s
K
17
1026
Mytens Model: BW-TSX
K
17
2079
Avail
K
17
2809
OTC Combo TENS/EMS System
K
17
1599
WiTouch Pro, WiTouch, Neubac
K
16
3611
Pain Therapy Device
K
16
3166
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
K
16
3393
Hi-Dow Wireless TENS/EMS System (Model HD-SN)
K
16
3153
Livia
K
17
0659
IQ Technologies
K
16
2392
Avazzia
K
17
0205
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
K
17
0145
Digital TENS Unit
K
16
2517
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
K
16
2479
Smart Pain Reliever, Model LT5019
K
16
2630
CP Relief Wand-OTC
K
16
1453
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
K
16
0508
Electronic Pulse Stimulator
K
16
1537
OTC TENS Device, Model PTS-IV
K
15
1995
Painmaster MCT Patch
K
16
0255
HBOTC Muscle and Nerve Stimulator
K
16
0893
HANAROCare ReJu
K
16
0115
Heat Pain Pro
K
16
0052
CUR Model 1
K
15
3520
Electronic Pulse Stimulator
K
15
0277
Pain Therapy System, Model PTS-II
K
15
2374
LL TENS 160A, LL TENS 160B
K
15
2954
Quell
K
15
2128
2-in-1 Abdominal Muscle Training & Back Pain Relief System
K
15
2852
ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)
K
15
1279
Counter OTC TENS Device, Model CSD-737Z
K
15
1034
PainKARE
K
15
0386
Tyece OTC TENS Device
K
15
0308
Palm TENS
K
15
1479
EV-820 OTC Pain Relief TENS
K
15
0043
Transcutaneous Electrical Nerve Stimulators (TENS)
K
15
1035
PulseRelief
K
14
3268
TENS AND POWERED MUSCLE STIMULATOR
K
15
0995
Electronic Pulse Stimulator
K
14
3430
SmartTENS
K
15
0681
GEMORE OTC TENS
K
13
3789
DOLPHIN NEUROSTIM OTC
K
14
2686
StimPad OTC
K
14
1978
MAXPOWER RELIEF
K
13
3502
5000Z FIREFLY SYSTEM
K
14
1299
OTC COMBO TENS/EMS SYSTEM
K
13
3929
HEALTH EXPERT ELCTRONIC STIMULATOR
K
14
1260
ELECTRONIC PULSE STIMULATOR
K
14
0168
EASYSTIM TN28_OTC
K
13
3979
TENS
K
13
1290
IQ TECHNOLOGIES
K
14
0333
ASCEND
K
14
0650
HIVOX ELECTRIC STIMULATOR OTC TENS
K
13
2993
COUNTER OTC TENS DEVICE
K
13
2563
PINOOK STIMULATOR
K
13
1956
QUICK RELAX PRO
K
13
3723
OTC PATCH
K
13
1910
MPP
K
13
1933
ELECTRONIC PULSE MASSAGER
K
13
1921
ELECTRONIC PULSE STIMULATOR
K
12
2410
I RUNE (I-200L)
K
13
0150
TCM MASSAGER
K
13
0802
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
K
12
3866
TANYX
K
13
1159
SMARTRELIEF
K
12
4055
T1040 AKA AURAWAVE
K
13
0114
PAINMASTER MCT PATCH
K
12
2744
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
K
12
1757
HEALTHMATEFOREVER
K
12
1353
MINI PATCH
K
11
3321
TENS BACK PAIN RELIEF SYSTEM
K
12
0500
THE PAIN PILOT (A.K.A PAIN PILOT)
K
11
2392
HIVOX BIOTEK INC.
K
11
3037
PAIN-AID
K
11
0068
MODEL PM3030
K
11
2415
LIFECARE ARM & LEG PAIN RELIEF SYSTEM
K
11
0716
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
K
11
0707
CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
K
10
2051
PAIN BUDDY
K
10
2598
HI-DOW-XP
K
10
0441
XINIWAVE, MODEL XW-18
K
10
0116
LASERTOUCHONE (OTC)
K
09
1757
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
K
09
0042
PAINMASTER MCT PATCH
K
06
0846
THERAPEUTIC MASSAGE COMPANION
K
06
3743
RHYTHM TOUCH Q 2-WAY
K
06
2532
ELECTROPULSE - LOW BACK PAIN
K
06
3660
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
K
06
0222
LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP
K
05
2785
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
K
03
3122
5000Z SYSTEM (OTC)
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
/
NUH
/
K233784
View Source
ENSO (Model 2)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233784
510(k) Type
Traditional
Applicant
Hinge Health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/23/2024
Days to Decision
88 days
Submission Type
Summary