FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Miscellaneous
Miscellaneous
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
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
K
24
1193
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
2
Cleared 510(K)
K
24
3644
Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
2
Cleared 510(K)
K
24
3355
Ceragem Automatic Thermal Massager (CGM-MB-1902)
2
Cleared 510(K)
K
24
0168
N7-S
2
Cleared 510(K)
K
22
0572
Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
2
Cleared 510(K)
K
20
2937
Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
2
Cleared 510(K)
K
20
2113
Ceragem Automatic Thermal Massager, Model CGM-MB-1901
2
Cleared 510(K)
K
15
3054
N5-1
2
Cleared 510(K)
K
14
0592
CERAGEM AUTOMATIC THERMAL MASSAGER
2
Cleared 510(K)
K
11
1588
LEGACY-500
2
Cleared 510(K)
K
11
1941
CHOYANG THERMAL MASSAGER
2
Cleared 510(K)
K
10
2938
ACQPOINT THERMAJADE MASSAGE TABLE
2
Cleared 510(K)
K
11
1329
NM-7000
2
Cleared 510(K)
K
10
2281
THERMAL MASSAGE BED, MODEL 2D-GX
2
Cleared 510(K)
K
09
2731
VIBRO-TRAC
2
Cleared 510(K)
K
08
0554
INAREX, MODEL 2D-LX
2
Cleared 510(K)
K
07
0672
MASSAGE MATTRESS VM9100RM
2
Cleared 510(K)
K
06
3034
AIR-FLEX WITH AUTO-DISTRACTION
2
Cleared 510(K)
K
06
2476
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
2
Cleared 510(K)
K
04
0031
CERAGEM-C THERMAL ACUPRESSURE MASSAGER
2
Cleared 510(K)
K
04
1200
THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
2
Cleared 510(K)
K
03
2449
THERMASSAGE ENERGY PRODUCT, MODEL HY5000
2
Cleared 510(K)
K
01
0252
MAGNUM
2
Cleared 510(K)
K
00
2390
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
2
Cleared 510(K)
K
99
3461
QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
2
Cleared 510(K)
K
98
0021
EXTENTRAC
2
Cleared 510(K)
K
97
4626
P.T. MACHINE
2
Cleared 510(K)
K
97
1046
HANDIFLEX
2
Cleared 510(K)
K
93
2810
THE HILL ADJUSTABLE AIR-FLEX MODEL
2
Cleared 510(K)
K
94
5954
MODELS 4100 AND 4300 MULTITHERAPY
2
Cleared 510(K)
K
94
3973
EURO TECH STERLING ROLLER TABLE
2
Cleared 510(K)
K
93
3443
COMBI 2.5 INTERSEGMENTAL TRACTION TABLE
2
Cleared 510(K)
K
92
4293
HERITAGE 10
2
Cleared 510(K)
K
93
0259
TRACTION TABLE MODEL #825-200
2
Cleared 510(K)
K
92
6316
TRUE-TRAC, STRATUS
2
Cleared 510(K)
K
92
2980
745-M (MAGNUM)
2
Cleared 510(K)
K
91
5784
INTERSEGMENTAL TRACTION TABLE
2
Cleared 510(K)
K
91
1574
PNEU-WAVE
2
Cleared 510(K)
K
90
5756
TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE
2
Cleared 510(K)
K
90
1971
COMFORTRAC TABLE MODEL CT-1000
2
Cleared 510(K)
K
90
1526
PRO TREATMENT TABLE
2
Cleared 510(K)
K
90
0304
IST-200 INTERSEGMENTAL TRACTION TABLE
2
Cleared 510(K)
K
89
5343
PRENATAL WEDGE
2
Cleared 510(K)
K
88
3357
MODEL 1080 ROLLER MASSAGE TABLE
2
Cleared 510(K)
K
88
2917
HI-LO TABLE, MODEL 820-05
2
Cleared 510(K)
K
88
1804
MULTI-FLEX TABLE--MODEL 200
2
Cleared 510(K)
K
88
1902
HEALTHTRONIC OMEGA TRAC
2
Cleared 510(K)
K
87
0712
MULTI-FLEX TABLE -- MODEL 103
2
Cleared 510(K)
K
87
0711
MULTI-FLEX TABLE -- MODEL 102
2
Cleared 510(K)
K
87
0710
MULTI-FLEX TABLE -- MODEL 101
2
Cleared 510(K)
K
87
0715
MULTI-FLEX TABLE -- MODEL 106
2
Cleared 510(K)
K
87
0714
MULTI-FLEX TABLE -- MODEL 105
2
Cleared 510(K)
K
87
0713
MULTI-FLEX TABLE -- MODEL 104
2
Cleared 510(K)
K
87
0427
EXTENSION/OSCILLATOR TABLE
2
Cleared 510(K)
K
86
2411
THE RELAXARE EXERCISE AND MASSAGE UNIT
2
Cleared 510(K)
K
86
2022
LIC-ORTHION MULTI-THERAPY TREATMENT TABLE
2
Cleared 510(K)
K
86
1554
PORT-A-TRAC
2
Cleared 510(K)
K
85
1328
KINETIC AUTO TECHNIC K.A.T. TABLE
2
Cleared 510(K)
K
84
4233
AUTOTRACTION TABLE
2
Cleared 510(K)
K
84
3572
PDB II VIBRATING DRAINAGE BED
2
Cleared 510(K)
K
83
2464
MASSAGE TABLE AAT-100
2
Cleared 510(K)
K
83
1394
SOMATRON
2
Cleared 510(K)
K
82
2413
WEYLAND EXTENSION VIBRATOR
2
Cleared 510(K)
K
83
0875
S & W MODEL 29
2
Cleared 510(K)
K
82
2693
ACU-MASSAGE TABLE
2
Cleared 510(K)
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
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 May 2025 at 11:05 pm
PM
/
subpart-f—physical-medicine-therapeutic-devices
/
JFB
/
K901971
View Source
COMFORTRAC TABLE MODEL CT-1000
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K901971
510(k) Type
Traditional
Applicant
COMFORTRAC SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/25/1990
Days to Decision
85 days
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
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
K
24
1193
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
K
24
3644
Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
K
24
3355
Ceragem Automatic Thermal Massager (CGM-MB-1902)
K
24
0168
N7-S
K
22
0572
Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
K
20
2937
Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
K
20
2113
Ceragem Automatic Thermal Massager, Model CGM-MB-1901
K
15
3054
N5-1
K
14
0592
CERAGEM AUTOMATIC THERMAL MASSAGER
K
11
1588
LEGACY-500
K
11
1941
CHOYANG THERMAL MASSAGER
K
10
2938
ACQPOINT THERMAJADE MASSAGE TABLE
K
11
1329
NM-7000
K
10
2281
THERMAL MASSAGE BED, MODEL 2D-GX
K
09
2731
VIBRO-TRAC
K
08
0554
INAREX, MODEL 2D-LX
K
07
0672
MASSAGE MATTRESS VM9100RM
K
06
3034
AIR-FLEX WITH AUTO-DISTRACTION
K
06
2476
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER
K
04
0031
CERAGEM-C THERMAL ACUPRESSURE MASSAGER
K
04
1200
THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
K
03
2449
THERMASSAGE ENERGY PRODUCT, MODEL HY5000
K
01
0252
MAGNUM
K
00
2390
QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
K
99
3461
QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
K
98
0021
EXTENTRAC
K
97
4626
P.T. MACHINE
K
97
1046
HANDIFLEX
K
93
2810
THE HILL ADJUSTABLE AIR-FLEX MODEL
K
94
5954
MODELS 4100 AND 4300 MULTITHERAPY
K
94
3973
EURO TECH STERLING ROLLER TABLE
K
93
3443
COMBI 2.5 INTERSEGMENTAL TRACTION TABLE
K
92
4293
HERITAGE 10
K
93
0259
TRACTION TABLE MODEL #825-200
K
92
6316
TRUE-TRAC, STRATUS
K
92
2980
745-M (MAGNUM)
K
91
5784
INTERSEGMENTAL TRACTION TABLE
K
91
1574
PNEU-WAVE
K
90
5756
TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE
K
90
1971
COMFORTRAC TABLE MODEL CT-1000
K
90
1526
PRO TREATMENT TABLE
K
90
0304
IST-200 INTERSEGMENTAL TRACTION TABLE
K
89
5343
PRENATAL WEDGE
K
88
3357
MODEL 1080 ROLLER MASSAGE TABLE
K
88
2917
HI-LO TABLE, MODEL 820-05
K
88
1804
MULTI-FLEX TABLE--MODEL 200
K
88
1902
HEALTHTRONIC OMEGA TRAC
K
87
0712
MULTI-FLEX TABLE -- MODEL 103
K
87
0711
MULTI-FLEX TABLE -- MODEL 102
K
87
0710
MULTI-FLEX TABLE -- MODEL 101
K
87
0715
MULTI-FLEX TABLE -- MODEL 106
K
87
0714
MULTI-FLEX TABLE -- MODEL 105
K
87
0713
MULTI-FLEX TABLE -- MODEL 104
K
87
0427
EXTENSION/OSCILLATOR TABLE
K
86
2411
THE RELAXARE EXERCISE AND MASSAGE UNIT
K
86
2022
LIC-ORTHION MULTI-THERAPY TREATMENT TABLE
K
86
1554
PORT-A-TRAC
K
85
1328
KINETIC AUTO TECHNIC K.A.T. TABLE
K
84
4233
AUTOTRACTION TABLE
K
84
3572
PDB II VIBRATING DRAINAGE BED
K
83
2464
MASSAGE TABLE AAT-100
K
83
1394
SOMATRON
K
82
2413
WEYLAND EXTENSION VIBRATOR
K
83
0875
S & W MODEL 29
K
82
2693
ACU-MASSAGE TABLE
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
/
subpart-f—physical-medicine-therapeutic-devices
/
JFB
/
K901971
View Source
COMFORTRAC TABLE MODEL CT-1000
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K901971
510(k) Type
Traditional
Applicant
COMFORTRAC SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/25/1990
Days to Decision
85 days