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
K
95
5160
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER
1
Cleared 510(K)
K
95
5250
QI GONG MASSAGER
1
Cleared 510(K)
K
95
4203
MASSAGER THERAPUTIC, ELECTRIC
1
Cleared 510(K)
K
95
2916
SHIATSU MASTER MASSAGER CUSHION
1
Cleared 510(K)
K
95
1414
CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR
1
Cleared 510(K)
K
95
0441
CONAIR FAMILY FITNESS BODY ENERGY
1
Cleared 510(K)
K
94
6382
SKALPI 3200
1
Cleared 510(K)
K
95
0410
CONAIR BODY AND SOLE
1
Cleared 510(K)
K
94
4909
WAHL FRESH FACE
1
Cleared 510(K)
K
95
0400
HAND MASSAGE UNIT
1
Cleared 510(K)
K
94
5603
CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)
1
Cleared 510(K)
K
94
0582
MASSAGING HELMET C.F. HANSEN DESIGN
1
Cleared 510(K)
K
94
3730
SQUEEZE PLAY
1
Cleared 510(K)
K
94
1412
WAHL COMPACT COMFORT MASSAGER
1
Cleared 510(K)
K
94
0837
WAHL(R) FOOT COMFORT MASSAGER
1
Cleared 510(K)
K
93
4886
NEXT WAVE PHYSIOACOUSTIC MATTRESS
1
Cleared 510(K)
K
93
1637
A013 FEMI-FORM FACIAL MASSAGER
1
Cleared 510(K)
K
93
1640
AO11 BODY MASSAGER
1
Cleared 510(K)
K
93
1638
FO96 HANDY MASSAGER
1
Cleared 510(K)
K
93
1639
F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR
1
Cleared 510(K)
K
93
3974
WINDMERE MASSAGE MATE
1
Cleared 510(K)
K
92
3238
SONASSAGE
1
Cleared 510(K)
K
93
1819
CARAPACE SUTURE REMOVAL TRAYS
1
Cleared 510(K)
K
92
4584
HEALTH ESSENTIALS FANCY PERSONAL MASSAGER
1
Cleared 510(K)
K
92
4581
HEALTH ESSENTIALS MAXI MASSAGER
1
Cleared 510(K)
K
92
4582
HEALTH ESSENTIALS BODY CARE MASSAGER
1
Cleared 510(K)
K
92
4583
HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER
1
Cleared 510(K)
K
92
4519
BODYTHERM
1
Cleared 510(K)
K
92
4431
HEALTLH ESSENTIALS PERSONAL MASSAGER
1
Cleared 510(K)
K
93
1086
WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER
1
Cleared 510(K)
K
92
0487
MINI VIBRATOR
1
Cleared 510(K)
K
91
3439
SONIX...THERAPEUTIC SONIC MASSAGE
1
Cleared 510(K)
K
91
3998
PAM PLUS
1
Cleared 510(K)
K
91
5242
TOUCH N TONE 1 MASSAGER
1
Cleared 510(K)
K
91
4830
A101 LITESSAGER
1
Cleared 510(K)
K
91
4829
FO92 SEATING MASSAGER
1
Cleared 510(K)
K
91
4706
FO51/F151 GOLF MASSAGER
1
Cleared 510(K)
K
91
4705
FO41 BODY MASSAGER
1
Cleared 510(K)
K
91
4704
FO69 FANCY MASSAGER
1
Cleared 510(K)
K
91
4703
F383 RECHARGEABLE MINI MASSAGER
1
Cleared 510(K)
K
91
4707
F055 B.O. FANTASTIC RELAXER
1
Cleared 510(K)
K
91
4344
MULTI-REACH II WAND MASSAGER
1
Cleared 510(K)
K
91
2659
SOUND RELIEF
1
Cleared 510(K)
K
91
2479
MOTOR MASSAGE PILLOW
1
Cleared 510(K)
K
90
5836
ULTRA WAVE 101
1
Cleared 510(K)
K
90
3098
MINI-VIBRATOR
1
Cleared 510(K)
K
90
1931
LEG EEZE
1
Cleared 510(K)
K
89
6947
CHIROPRACTIC MASSAGE PILLOW
1
Cleared 510(K)
K
88
3913
LA MASSEUSE
1
Cleared 510(K)
K
87
1107
VASOTRAIN 447
1
Cleared 510(K)
K
87
0972
SONAFON, THERAPEUTIC MASSAGER
1
Cleared 510(K)
K
86
0159
THUMPER (VIBRATOR/MASSAGER)
1
Cleared 510(K)
K
85
0495
AKUFON THERAPEUTIC MASSAGER
1
Cleared 510(K)
K
84
2379
ELECTRO-SAGE MODEL 203
1
Cleared 510(K)
K
83
3370
LINEAR VIBRATION A MCSHIRLEY PRODUCT
1
Cleared 510(K)
K
83
0715
NORELCO VIBRATING BOARD V900
1
Cleared 510(K)
K
82
1133
ELECTRICAL VIBRATING DEVICE
1
Cleared 510(K)
K
82
1633
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
1
Cleared 510(K)
K
81
2902
ACUPRESS VIBRATOR
1
Cleared 510(K)
K
81
0446
VIBRATOR
1
Cleared 510(K)
K
81
0244
PORTA-PULS MUSCLE STIMULATOR
1
Cleared 510(K)
K
80
0250
HMB-200
1
Cleared 510(K)
K
80
0018
BK-5203 FACILITATION VIBRATOR ELECTRIC
1
Cleared 510(K)
K
77
1279
HEAD FACILITATION VIBRATOR BK-5210
1
Cleared 510(K)
K
76
1121
ELECTRIC VIBRATOR
1
Cleared 510(K)
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
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 May 2025 at 11:05 pm
PM
/
subpart-f—physical-medicine-therapeutic-devices
/
IRO
/
K915242
View Source
TOUCH N TONE 1 MASSAGER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K915242
510(k) Type
Traditional
Applicant
CONAIR CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/20/1991
Days to Decision
37 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
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
K
95
5160
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER
K
95
5250
QI GONG MASSAGER
K
95
4203
MASSAGER THERAPUTIC, ELECTRIC
K
95
2916
SHIATSU MASTER MASSAGER CUSHION
K
95
1414
CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR
K
95
0441
CONAIR FAMILY FITNESS BODY ENERGY
K
94
6382
SKALPI 3200
K
95
0410
CONAIR BODY AND SOLE
K
94
4909
WAHL FRESH FACE
K
95
0400
HAND MASSAGE UNIT
K
94
5603
CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)
K
94
0582
MASSAGING HELMET C.F. HANSEN DESIGN
K
94
3730
SQUEEZE PLAY
K
94
1412
WAHL COMPACT COMFORT MASSAGER
K
94
0837
WAHL(R) FOOT COMFORT MASSAGER
K
93
4886
NEXT WAVE PHYSIOACOUSTIC MATTRESS
K
93
1637
A013 FEMI-FORM FACIAL MASSAGER
K
93
1640
AO11 BODY MASSAGER
K
93
1638
FO96 HANDY MASSAGER
K
93
1639
F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR
K
93
3974
WINDMERE MASSAGE MATE
K
92
3238
SONASSAGE
K
93
1819
CARAPACE SUTURE REMOVAL TRAYS
K
92
4584
HEALTH ESSENTIALS FANCY PERSONAL MASSAGER
K
92
4581
HEALTH ESSENTIALS MAXI MASSAGER
K
92
4582
HEALTH ESSENTIALS BODY CARE MASSAGER
K
92
4583
HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER
K
92
4519
BODYTHERM
K
92
4431
HEALTLH ESSENTIALS PERSONAL MASSAGER
K
93
1086
WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER
K
92
0487
MINI VIBRATOR
K
91
3439
SONIX...THERAPEUTIC SONIC MASSAGE
K
91
3998
PAM PLUS
K
91
5242
TOUCH N TONE 1 MASSAGER
K
91
4830
A101 LITESSAGER
K
91
4829
FO92 SEATING MASSAGER
K
91
4706
FO51/F151 GOLF MASSAGER
K
91
4705
FO41 BODY MASSAGER
K
91
4704
FO69 FANCY MASSAGER
K
91
4703
F383 RECHARGEABLE MINI MASSAGER
K
91
4707
F055 B.O. FANTASTIC RELAXER
K
91
4344
MULTI-REACH II WAND MASSAGER
K
91
2659
SOUND RELIEF
K
91
2479
MOTOR MASSAGE PILLOW
K
90
5836
ULTRA WAVE 101
K
90
3098
MINI-VIBRATOR
K
90
1931
LEG EEZE
K
89
6947
CHIROPRACTIC MASSAGE PILLOW
K
88
3913
LA MASSEUSE
K
87
1107
VASOTRAIN 447
K
87
0972
SONAFON, THERAPEUTIC MASSAGER
K
86
0159
THUMPER (VIBRATOR/MASSAGER)
K
85
0495
AKUFON THERAPEUTIC MASSAGER
K
84
2379
ELECTRO-SAGE MODEL 203
K
83
3370
LINEAR VIBRATION A MCSHIRLEY PRODUCT
K
83
0715
NORELCO VIBRATING BOARD V900
K
82
1133
ELECTRICAL VIBRATING DEVICE
K
82
1633
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
K
81
2902
ACUPRESS VIBRATOR
K
81
0446
VIBRATOR
K
81
0244
PORTA-PULS MUSCLE STIMULATOR
K
80
0250
HMB-200
K
80
0018
BK-5203 FACILITATION VIBRATOR ELECTRIC
K
77
1279
HEAD FACILITATION VIBRATOR BK-5210
K
76
1121
ELECTRIC VIBRATOR
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
/
subpart-f—physical-medicine-therapeutic-devices
/
IRO
/
K915242
View Source
TOUCH N TONE 1 MASSAGER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K915242
510(k) Type
Traditional
Applicant
CONAIR CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/20/1991
Days to Decision
37 days
Submission Type
Statement