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Cardiovascular
Review Panel
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Review Panel
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Review Panel
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Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
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Obstetrical and Gynecological
Review Panel
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Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
MOC
Cushion, Flotation, Therapeutic
2
Product Code
IMG
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
2
Product Code
IMI
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
2
Product Code
K
23
0472
Sonopuls 190
2
Cleared 510(K)
K
22
2098
ManaSport+
2
Cleared 510(K)
K
21
0284
ManaSport
2
Cleared 510(K)
K
20
2788
Sonomed IV, Sonomed V
2
Cleared 510(K)
K
16
0378
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
2
Cleared 510(K)
K
16
1628
JAS Pulse(TM) Ultrasonic Therapy
2
Cleared 510(K)
K
16
0075
Accent XL
2
Cleared 510(K)
K
16
1502
MC1 Plus
2
Cleared 510(K)
K
14
2976
UltraTENS
2
Cleared 510(K)
K
13
1309
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
2
Cleared 510(K)
K
13
0888
SONOPULSE/ SONOPULSE III
2
Cleared 510(K)
K
12
4010
ACCUSONIC ADVANTAGE
2
Cleared 510(K)
K
12
0171
ACCUSONIC ADVANTAGE
2
Cleared 510(K)
K
11
2520
US-101L, US-103S
2
Cleared 510(K)
K
09
1615
MED CONTOUR
2
Cleared 510(K)
K
09
0542
SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
2
Cleared 510(K)
K
06
2256
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM
2
Cleared 510(K)
K
05
3041
MED SCULPT
2
Cleared 510(K)
K
05
2934
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
2
Cleared 510(K)
K
05
3546
SONICATOR 740, MODEL ME 740
2
Cleared 510(K)
K
05
0410
HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)
2
Cleared 510(K)
K
04
0798
HES ULTRASONIC THERAPY APPLIANCE
2
Cleared 510(K)
K
03
1116
VECTRA (INTELECT) EPR ULTRASOUND
2
Cleared 510(K)
K
02
4013
SUN-RAIN ULTRASONIC THERAPY, SU-100
2
Cleared 510(K)
K
03
1329
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
2
Cleared 510(K)
K
03
2793
US-100 PORTABLE ULTRASOUND THERAPY UNIT
2
Cleared 510(K)
K
02
4307
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
2
Cleared 510(K)
K
03
0878
ACCOUSONIC, MODEL AS-270
2
Cleared 510(K)
K
03
0410
ACCOUSONIC PLUS, MODEL AP-170
2
Cleared 510(K)
K
02
1483
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
2
Cleared 510(K)
K
01
3192
SONICATOR PLUS 930, MODEL ME 930
2
Cleared 510(K)
K
01
0702
XUB EXTERNAL ULTRASOUND
2
Cleared 510(K)
K
01
1955
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
2
Cleared 510(K)
K
01
0609
ACCUSONIC, MODEL AS-260
2
Cleared 510(K)
K
01
0102
SONIC MODEL SO-300
2
Cleared 510(K)
K
99
1613
SW ULTRASOUND, MODELS 331, 311, 333
2
Cleared 510(K)
K
00
0593
SONIC, MODEL SO-100
2
Cleared 510(K)
K
00
0084
ENRAF-NONIUS SONOPULS 190 SYSTEM
2
Cleared 510(K)
K
00
1370
ACCUSONIC PLUS, MODEL AP-100
2
Cleared 510(K)
K
00
0604
NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT
2
Cleared 510(K)
K
98
4199
EXONIX
2
Cleared 510(K)
K
98
1449
SD-956 ULTRASOUND THERAPY
2
Cleared 510(K)
K
98
2544
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
2
Cleared 510(K)
K
98
2829
FORTE, MODEL CPS ULTRASOUND
2
Cleared 510(K)
K
97
3024
INTELECT LEGEND ULTRASOUND
2
Cleared 510(K)
K
97
0131
ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE
2
Cleared 510(K)
K
96
1250
DYNATRON 125 ULTRASOUND
2
Cleared 510(K)
K
96
0802
CUSHMAN MANUFACTURING, INC. ULTRA 6.0.
2
Cleared 510(K)
K
95
4136
MATRIX MICROSON 410
2
Cleared 510(K)
K
95
2536
SONO 5
2
Cleared 510(K)
K
94
4596
GRAHAM-FIELD ULTRASOUND LOTION
2
Cleared 510(K)
K
95
0564
RICH-MAR US-II ULTRASOUND
2
Cleared 510(K)
K
93
0307
INTELECT 222 P
2
Cleared 510(K)
K
93
0186
INTERTRON 6000/6100
2
Cleared 510(K)
K
92
2839
MID-CANADA MEDICAL
2
Cleared 510(K)
K
92
3076
ULTRA SX
2
Cleared 510(K)
K
92
0983
SONOPULS 590
2
Cleared 510(K)
K
91
5557
RICH-MAR MODEL 510 ULTRASOUND
2
Cleared 510(K)
K
91
3981
RICH-MAR MODEL II ULTRASOUND
2
Cleared 510(K)
K
91
2202
RICH-MAR MODEL 25 ULTRASOUND
2
Cleared 510(K)
K
91
0708
RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE
2
Cleared 510(K)
K
90
4051
RICH-MAR MODEL V ULTRASOUND
2
Cleared 510(K)
K
90
1950
DITER ULTRASONIC S 3000
2
Cleared 510(K)
K
89
4152
MEDITHERM
2
Cleared 510(K)
K
88
3228
SONICATOR 720 (MODEL ME720)
2
Cleared 510(K)
K
88
1211
TRU-TECH 310 ULTRASOUND THERAPY UNIT #310
2
Cleared 510(K)
K
87
5381
ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER
2
Cleared 510(K)
K
88
0901
SONICATOR 710 (MODEL ME710)
2
Cleared 510(K)
K
88
0602
MODIFIED SONICATOR 720, MODEL ME720
2
Cleared 510(K)
K
87
3812
SONICATOR 720 (MODEL ME720)
2
Cleared 510(K)
K
87
2393
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
2
Cleared 510(K)
K
86
0099
MEDCO-SONIC NQ-2000
2
Cleared 510(K)
K
85
1937
SONOMED 4
2
Cleared 510(K)
K
85
1397
SONICATOR 705 MODEL ME 705
2
Cleared 510(K)
K
85
0640
SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT
2
Cleared 510(K)
K
84
4386
ESCOTEK-EST 301A ULTRA-SONIC UNIT
2
Cleared 510(K)
K
84
4036
US 610
2
Cleared 510(K)
K
84
3372
OMNISOUND THERAPY UNIT
2
Cleared 510(K)
K
84
3221
MEGASON MODEL 150
2
Cleared 510(K)
K
84
1446
INTELECT 200 THERAPEUTIC ULTRASOUND
2
Cleared 510(K)
K
84
1447
INTELECT 210 PORTABLE ULTRASOUND
2
Cleared 510(K)
K
84
1445
INTELECT 205 PORTABLE ULTRASOUND UNIT
2
Cleared 510(K)
K
81
3593
INTELECT MODEL 200
2
Cleared 510(K)
K
81
2752
MICRO MED INT'L MICRO SOUND US-100
2
Cleared 510(K)
K
81
1159
DYNASOUND 801
2
Cleared 510(K)
K
80
0632
MODEL 118 PULSE MEGASON
2
Cleared 510(K)
K
79
1976
DYNASOUND 601
2
Cleared 510(K)
K
78
1317
ULTRASONIC THERAPY APPARATUS, 407
2
Cleared 510(K)
IMJ
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
2
Product Code
QOL
Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
2
Product Code
QRA
Virtual Reality Behavioral Therapy Device For Pain Relief
2
Product Code
BXB
Exerciser, Powered
1
Product Code
EGJ
Device, Iontophoresis, Other Uses
2
Product Code
HPH
Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
3
Product Code
IKW
Utensil, Homemaking
1
Product Code
IKX
Aid, Transfer
1
Product Code
IKZ
Bed, Patient Rotation, Powered
2
Product Code
ILC
Utensil, Eating
1
Product Code
ILD
Adaptor, Dressing
1
Product Code
ILJ
Bath, Hydro-Massage
2
Product Code
ILK
Transport, Patient, Powered
2
Product Code
ILM
Bath, Sitz, Powered
2
Product Code
ILO
Pack, Hot Or Cold, Water Circulating
2
Product Code
ILS
Adaptor, Hygiene
1
Product Code
ILT
Adaptor, Recreational
1
Product Code
ILW
Adaptor, Grooming
1
Product Code
ILX
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
2
Product Code
ILY
Lamp, Infrared, Therapeutic Heating
2
Product Code
ILZ
Accessories, Traction
1
Product Code
IMA
Pack, Heat, Moist
1
Product Code
IMB
Cabinet, Moist Steam
2
Product Code
IMC
Bath, Paraffin
2
Product Code
IMD
Pack, Hot Or Cold, Disposable
1
Product Code
IME
Pack, Hot Or Cold, Reusable
1
Product Code
IMF
Unit, Chilling
1
Product Code
INX
Bed, Air Fluidized
2
Product Code
INY
Bed, Patient Rotation, Manual
1
Product Code
IOA
Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
2
Product Code
IOB
Lamp, Infrared, Non Heating
2
Product Code
IOD
Components, Exercise
1
Product Code
IOE
Bars, Parallel, Exercise
1
Product Code
IOG
Treadmill, Mechanical
1
Product Code
IOL
Treadmill, Powered
1
Product Code
ION
Exerciser, Non-Measuring
1
Product Code
IOQ
Bed, Flotation Therapy, Powered
2
Product Code
IPF
Stimulator, Muscle, Powered
2
Product Code
IRN
Device, Warning, Overload, External Limb, Powered
2
Product Code
IRO
Vibrator, Therapeutic
1
Product Code
IRP
Massager, Powered Inflatable Tube
2
Product Code
IRQ
Unit, Heating, Powered
1
Product Code
IRR
Bars, Parallel, Powered
1
Product Code
IRS
Head Halter, Traction
1
Product Code
IRT
Pad, Heating, Powered
2
Product Code
ISA
Massager, Therapeutic, Electric
1
Product Code
ISD
Exerciser, Measuring
2
Product Code
ITH
Equipment, Traction, Powered
2
Product Code
JFA
Exerciser, Finger, Powered
1
Product Code
JFB
Table, Physical Therapy, Multi Function
2
Product Code
KNL
Board, Scooter, Prone
1
Product Code
KNM
Device, Pressure Applying
1
Product Code
KTB
Device, Iontophoresis, Specific Uses
2
Product Code
KTC
Bath, Sitz, Nonpowered
1
Product Code
LBG
Device, Fluidized Therapy, Dry Heat
2
Product Code
LSB
Unit, Fluidotherapy
2
Product Code
LXF
Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
3
Product Code
LXJ
Interactive Rehabilitation Exercise Devices
2
Product Code
LYG
Massager, Therapeutic, Manual
1
Product Code
MPO
Infant Heel Warmer (Chemical Heat Pack)
1
Product Code
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
2
Product Code
NHN
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
2
Product Code
NYY
Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
2
Product Code
NYZ
Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning
2
Product Code
OMW
Adhesive Backed Thermal Skin Patches
1
Product Code
OSD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
2
Product Code
PCD
Powered Stairway Chair Lift
2
Product Code
PFW
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
2
Product Code
PHW
Cold Pack And Vibrating Massager
1
Product Code
PKS
Exerciser, Non-Measuring For Stroke Rehabilitation
1
Product Code
PQY
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
2
Product Code
QKC
Interactive Rehabilitation Exercise Device, Prescription Use
2
Product Code
QKD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use
2
Product Code
QTC
Adult Portable Bed Rails For Medical Purposes
1
Product Code
Radiology
Review Panel
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Review Panel
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Review Panel
Medical Genetics
Review Panel
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Review Panel
Last synced on 2 May 2025 at 11:05 pm
PM
/
subpart-f—physical-medicine-therapeutic-devices
/
IMI
/
K930307
View Source
INTELECT 222 P
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K930307
510(k) Type
Traditional
Applicant
CHATTANOOGA GROUP, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/2/1993
Days to Decision
162 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Miscellaneous
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
MOC
Cushion, Flotation, Therapeutic
IMG
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IMI
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
K
23
0472
Sonopuls 190
K
22
2098
ManaSport+
K
21
0284
ManaSport
K
20
2788
Sonomed IV, Sonomed V
K
16
0378
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
K
16
1628
JAS Pulse(TM) Ultrasonic Therapy
K
16
0075
Accent XL
K
16
1502
MC1 Plus
K
14
2976
UltraTENS
K
13
1309
SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ
K
13
0888
SONOPULSE/ SONOPULSE III
K
12
4010
ACCUSONIC ADVANTAGE
K
12
0171
ACCUSONIC ADVANTAGE
K
11
2520
US-101L, US-103S
K
09
1615
MED CONTOUR
K
09
0542
SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900
K
06
2256
HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM
K
05
3041
MED SCULPT
K
05
2934
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
K
05
3546
SONICATOR 740, MODEL ME 740
K
05
0410
HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)
K
04
0798
HES ULTRASONIC THERAPY APPLIANCE
K
03
1116
VECTRA (INTELECT) EPR ULTRASOUND
K
02
4013
SUN-RAIN ULTRASONIC THERAPY, SU-100
K
03
1329
DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
K
03
2793
US-100 PORTABLE ULTRASOUND THERAPY UNIT
K
02
4307
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
K
03
0878
ACCOUSONIC, MODEL AS-270
K
03
0410
ACCOUSONIC PLUS, MODEL AP-170
K
02
1483
RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
K
01
3192
SONICATOR PLUS 930, MODEL ME 930
K
01
0702
XUB EXTERNAL ULTRASOUND
K
01
1955
MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
K
01
0609
ACCUSONIC, MODEL AS-260
K
01
0102
SONIC MODEL SO-300
K
99
1613
SW ULTRASOUND, MODELS 331, 311, 333
K
00
0593
SONIC, MODEL SO-100
K
00
0084
ENRAF-NONIUS SONOPULS 190 SYSTEM
K
00
1370
ACCUSONIC PLUS, MODEL AP-100
K
00
0604
NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT
K
98
4199
EXONIX
K
98
1449
SD-956 ULTRASOUND THERAPY
K
98
2544
RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
K
98
2829
FORTE, MODEL CPS ULTRASOUND
K
97
3024
INTELECT LEGEND ULTRASOUND
K
97
0131
ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE
K
96
1250
DYNATRON 125 ULTRASOUND
K
96
0802
CUSHMAN MANUFACTURING, INC. ULTRA 6.0.
K
95
4136
MATRIX MICROSON 410
K
95
2536
SONO 5
K
94
4596
GRAHAM-FIELD ULTRASOUND LOTION
K
95
0564
RICH-MAR US-II ULTRASOUND
K
93
0307
INTELECT 222 P
K
93
0186
INTERTRON 6000/6100
K
92
2839
MID-CANADA MEDICAL
K
92
3076
ULTRA SX
K
92
0983
SONOPULS 590
K
91
5557
RICH-MAR MODEL 510 ULTRASOUND
K
91
3981
RICH-MAR MODEL II ULTRASOUND
K
91
2202
RICH-MAR MODEL 25 ULTRASOUND
K
91
0708
RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE
K
90
4051
RICH-MAR MODEL V ULTRASOUND
K
90
1950
DITER ULTRASONIC S 3000
K
89
4152
MEDITHERM
K
88
3228
SONICATOR 720 (MODEL ME720)
K
88
1211
TRU-TECH 310 ULTRASOUND THERAPY UNIT #310
K
87
5381
ULTRASOUND DIATHERMY UNIT ULTRASOUND HEATER
K
88
0901
SONICATOR 710 (MODEL ME710)
K
88
0602
MODIFIED SONICATOR 720, MODEL ME720
K
87
3812
SONICATOR 720 (MODEL ME720)
K
87
2393
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
K
86
0099
MEDCO-SONIC NQ-2000
K
85
1937
SONOMED 4
K
85
1397
SONICATOR 705 MODEL ME 705
K
85
0640
SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT
K
84
4386
ESCOTEK-EST 301A ULTRA-SONIC UNIT
K
84
4036
US 610
K
84
3372
OMNISOUND THERAPY UNIT
K
84
3221
MEGASON MODEL 150
K
84
1446
INTELECT 200 THERAPEUTIC ULTRASOUND
K
84
1447
INTELECT 210 PORTABLE ULTRASOUND
K
84
1445
INTELECT 205 PORTABLE ULTRASOUND UNIT
K
81
3593
INTELECT MODEL 200
K
81
2752
MICRO MED INT'L MICRO SOUND US-100
K
81
1159
DYNASOUND 801
K
80
0632
MODEL 118 PULSE MEGASON
K
79
1976
DYNASOUND 601
K
78
1317
ULTRASONIC THERAPY APPARATUS, 407
IMJ
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
QOL
Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
QRA
Virtual Reality Behavioral Therapy Device For Pain Relief
BXB
Exerciser, Powered
EGJ
Device, Iontophoresis, Other Uses
HPH
Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat
IKW
Utensil, Homemaking
IKX
Aid, Transfer
IKZ
Bed, Patient Rotation, Powered
ILC
Utensil, Eating
ILD
Adaptor, Dressing
ILJ
Bath, Hydro-Massage
ILK
Transport, Patient, Powered
ILM
Bath, Sitz, Powered
ILO
Pack, Hot Or Cold, Water Circulating
ILS
Adaptor, Hygiene
ILT
Adaptor, Recreational
ILW
Adaptor, Grooming
ILX
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
ILY
Lamp, Infrared, Therapeutic Heating
ILZ
Accessories, Traction
IMA
Pack, Heat, Moist
IMB
Cabinet, Moist Steam
IMC
Bath, Paraffin
IMD
Pack, Hot Or Cold, Disposable
IME
Pack, Hot Or Cold, Reusable
IMF
Unit, Chilling
INX
Bed, Air Fluidized
INY
Bed, Patient Rotation, Manual
IOA
Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
IOB
Lamp, Infrared, Non Heating
IOD
Components, Exercise
IOE
Bars, Parallel, Exercise
IOG
Treadmill, Mechanical
IOL
Treadmill, Powered
ION
Exerciser, Non-Measuring
IOQ
Bed, Flotation Therapy, Powered
IPF
Stimulator, Muscle, Powered
IRN
Device, Warning, Overload, External Limb, Powered
IRO
Vibrator, Therapeutic
IRP
Massager, Powered Inflatable Tube
IRQ
Unit, Heating, Powered
IRR
Bars, Parallel, Powered
IRS
Head Halter, Traction
IRT
Pad, Heating, Powered
ISA
Massager, Therapeutic, Electric
ISD
Exerciser, Measuring
ITH
Equipment, Traction, Powered
JFA
Exerciser, Finger, Powered
JFB
Table, Physical Therapy, Multi Function
KNL
Board, Scooter, Prone
KNM
Device, Pressure Applying
KTB
Device, Iontophoresis, Specific Uses
KTC
Bath, Sitz, Nonpowered
LBG
Device, Fluidized Therapy, Dry Heat
LSB
Unit, Fluidotherapy
LXF
Diathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat
LXJ
Interactive Rehabilitation Exercise Devices
LYG
Massager, Therapeutic, Manual
MPO
Infant Heel Warmer (Chemical Heat Pack)
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
NHN
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
NYY
Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
NYZ
Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning
OMW
Adhesive Backed Thermal Skin Patches
OSD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
PCD
Powered Stairway Chair Lift
PFW
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
PHW
Cold Pack And Vibrating Massager
PKS
Exerciser, Non-Measuring For Stroke Rehabilitation
PQY
Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
QKC
Interactive Rehabilitation Exercise Device, Prescription Use
QKD
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use
QTC
Adult Portable Bed Rails For Medical Purposes
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
PM
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subpart-f—physical-medicine-therapeutic-devices
/
IMI
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K930307
View Source
INTELECT 222 P
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K930307
510(k) Type
Traditional
Applicant
CHATTANOOGA GROUP, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/2/1993
Days to Decision
162 days
Submission Type
Statement