Product Code: ISA
FDA class 1
21 CFR 890.5660
Massager, Therapeutic, Electric
Physical Medicine
An electric therapeutic massager is an electrically powered device that delivers mechanical massage to soft tissues for therapeutic purposes including pain relief, relaxation, and improvement of local blood flow. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISA, regulated under 21 CFR 890.5660, within the Physical Medicine medical specialty.
510(k)s
100
FEI Numbers
783
Registration Numbers
783
Unique Applicants
74
Years Active
48
Basic Information
- Product Code
- ISA
- Device Class
- FDA class 1
- Regulation Number
- 890.5660
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 100 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243488 | VMAT PRO | Feb 06, 2025 | Substantially Equivalent | TermoSalud |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | Jun 05, 2024 | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. |
| K221865 | BTL-094 | Apr 14, 2023 | Substantially Equivalent | BTL Industries Inc. |
| K210166 | Omnispec ED1000 | Jan 27, 2023 | Substantially Equivalent | Medispec Ltd. |
| K213120 | OW100S (model OW100S-US) | Oct 12, 2022 | Substantially Equivalent | Tissue Regeneration Technologies, LLC DBA as SoftWave TRT |
| K220538 | DolorClast Radial | Jul 11, 2022 | Substantially Equivalent | EMS Electro Medical Systems SA |
| K210451 | OrthoGold 100 | May 05, 2021 | Substantially Equivalent | Tissue Regeneration Technologies, LLC |
| K182682 | OrthoGold 100 | Dec 21, 2018 | Substantially Equivalent | Tissue Regeneration Technologies |
| K173692 | D-Actor 200 Vibration Massage System | Apr 13, 2018 | Substantially Equivalent | Storz Medical AG |
| K053225 | CELLU M6 KEYMODULE I | Nov 06, 2006 | Substantially Equivalent | LPG ONE, INC |
| K030876 | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | Jan 22, 2004 | Substantially Equivalent | CYNOSURE, INC. |
| K002908 | JET THERAPY | Aug 30, 2001 | Substantially Equivalent | JET THERAPY |
| K990445 | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR | Jan 18, 2000 | Substantially Equivalent | LPG USA, INC. |
| K952990 | SPIN ROLLERE | Sep 29, 1995 | Substantially Equivalent for Some Indications | KINSEI SHIATSU, INC. |
| K952041 | BODYFLEX MASSAGER | Aug 14, 1995 | Substantially Equivalent | TRURO'S ENT. |
| K950411 | RELAXU-1 | Aug 02, 1995 | Substantially Equivalent | KINSEI SHIATSU, INC. |
| K950931 | AVON MASSAGING HAIRBRUSH | Apr 05, 1995 | Substantially Equivalent for Some Indications | SIEGEL,MANDELL & DAVIDSON,P.C. |
| K950655 | THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES | Mar 07, 1995 | Substantially Equivalent for Some Indications | ULTRASSAGE, INC. |
| K950322 | RELAXY-THE WONDER HAND | Feb 14, 1995 | Substantially Equivalent for Some Indications | KINSEI SHIATSU, INC. |
| K950321 | SHAPE UP MOMI ROLLER | Feb 14, 1995 | Substantially Equivalent for Some Indications | KINSEI SHIATSU, INC. |
| K950320 | RELAXY-WONDER KNOCK | Feb 14, 1995 | Substantially Equivalent for Some Indications | KINSEI SHIATSU, INC. |
| K944885 | DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 | Feb 14, 1995 | Substantially Equivalent for Some Indications | KOLVIN INDUSTRIES LTD. |
| K944884 | DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B | Feb 14, 1995 | Substantially Equivalent for Some Indications | KOLVIN INDUSTRIES LTD. |
| K944730 | MASSAGER | Feb 14, 1995 | Substantially Equivalent for Some Indications | NORTH AMERICAN TECHNICAL SERVICES CORP. |
| K936178 | AGILANCE-GOLDEN SPOONS | Jan 18, 1995 | Substantially Equivalent for Some Indications | OISMULLER & PARTNER KEG |
| K944637 | FAMILY FITNESS SHIATSU MASSAGER | Dec 13, 1994 | Substantially Equivalent for Some Indications | CONAIR CORP. |
| K944024 | STIMU-TAP | Dec 08, 1994 | Substantially Equivalent | WAHL CLIPPER CORP. |
| K943092 | FAMILY FITNESS SHIATSU MASSAGER | Sep 29, 1994 | Substantially Equivalent | CONAIR CORP. |
| K942950 | BODY FLEX | Jul 26, 1994 | Substantially Equivalent for Some Indications | CONAIR CORP. |
| K942218 | SHIATSU MASSAGER | Jun 22, 1994 | Substantially Equivalent for Some Indications | WESTMINSTER INTERNATIONAL CO., INC. |
| K940621 | PRO-SHIATSU PORTABLE MASSAGER | Jun 22, 1994 | Substantially Equivalent for Some Indications | WESTMINSTER INTERNATIONAL CO., INC. |
| K942223 | BODY SYSTEM | Jun 09, 1994 | Substantially Equivalent for Some Indications | CONAIR CORP. |
| K941594 | WAHL DOUBLE COMFORT MASSAGER | Jun 09, 1994 | Substantially Equivalent for Some Indications | WAHL CLIPPER CORP. |
| K940683 | WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA | Jun 09, 1994 | Substantially Equivalent for Some Indications | WAHL CLIPPER CORP. |
| K940543 | MODEL 777 THERAPEUTIC MASSAGER | Apr 21, 1994 | Substantially Equivalent for Some Indications | VOYAGER MEDICAL CORP. |
| K940369 | BODY RECHARGER | Apr 21, 1994 | Substantially Equivalent for Some Indications | CONAIR CORP. |
| K925907 | AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER | Mar 30, 1994 | Substantially Equivalent | POLLENEX CORP. |
| K931636 | FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER | Mar 28, 1994 | Substantially Equivalent | FAIRFORM MFG., CO., LTD. |
| K935581 | OMRON MASSAGER MODEL HM-102 | Mar 04, 1994 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K935462 | OMBRON TWIN-HEAD MASSAGER MODEL HM-101 | Mar 04, 1994 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K935459 | OMRON MASSAGER MODEL HM-45 | Mar 04, 1994 | Substantially Equivalent | OMRON HEALTHCARE, INC. |
| K926339 | BODY RELAXER | Mar 04, 1994 | Substantially Equivalent | CONAIR CORP. |
| K911727 | INFRADERM; TOUCH 'N TONE PLUS | Feb 25, 1994 | Substantially Equivalent | CONAIR CORP. |
| K932904 | WINDMERE WAND MASSAGER | Feb 17, 1994 | Substantially Equivalent | WINDMERE CORP. |
| K924237 | WINDMERE PRELUDE III | Oct 18, 1993 | Substantially Equivalent | WINDMERE CORP. |
| K924518 | BODY SOOTHER | Oct 12, 1993 | Substantially Equivalent | CONAIR CORP. |
| K924520 | BODY TRAINER | Sep 30, 1993 | Substantially Equivalent | CONAIR CORP. |
| K925036 | HANDY VIBRO BELT | Jun 29, 1993 | Substantially Equivalent | COSMESEARCH, INC. |
| K923541 | BODY-MATE MASSAGER | Jun 24, 1993 | Substantially Equivalent | AMERICAN THERAPY PRODUCTS |
| K921000 | SONACARE SOUND MASSAGER | Mar 31, 1993 | Substantially Equivalent | HONOR TRADING, LTD. |
| K915729 | AUQASOOTHE/AQUA MED | Apr 29, 1992 | Substantially Equivalent | AQUASOOTHE |
| K914943 | AQUA MED | Apr 02, 1992 | Substantially Equivalent | AQUA MASSAGE INTL., INC. |
| K912822 | PERSONAL BODY MASSAGER, MODELS 1605 & 1606 | Feb 11, 1992 | Substantially Equivalent | RAYMOND INDUSTRIAL, LTD. |
| K912383 | VIBRATOUCH II CORDLESS WAND MASSAGER | Oct 07, 1991 | Substantially Equivalent | CONAIR CORP. |
| K912634 | CORDLESS ELECTRIC MASSAGER EV315 | Sep 12, 1991 | Substantially Equivalent | MATSUSHITA ELECTRIC CO. |
| K910519 | GOOD VIBRATIONS TUBE MASSAGER | Apr 01, 1991 | Substantially Equivalent | DUAL VOLTAGE, INC. |
| K904915 | CARESS MASSAGER | Nov 27, 1990 | Substantially Equivalent | KENDEX CORP. |
| K903617 | MUSCLE MASSAGER | Nov 26, 1990 | Substantially Equivalent | URI HALFON AND GABRIEL HERTZBERG |
| K904242 | QI-GONG MACHINE THERAPEUTIC MASSAGER | Oct 11, 1990 | Substantially Equivalent | CHINA HEALTHWAYS INSTITUTE |
| K901796 | PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE | Jun 06, 1990 | Substantially Equivalent | COMPONENT EQUIPMENT MFG., INC. |
| K900674 | CONSTI-SSAGE VIBRATOR/MASSAGE | Mar 02, 1990 | Substantially Equivalent | BIO-TECH CO. |
| K893029 | OMRON TRAVEL MASSAGER, MODEL HM-01 | May 31, 1989 | Substantially Equivalent | OMRON ELECTRONICS, INC. |
| K892669 | COMFORTRAC, CT90 & CT100 BI-PHASICS | May 26, 1989 | Substantially Equivalent | COMFORTRAC SYSTEMS |
| K891871 | PHASER (SINGLE LINEAR MECHANICAL MASSAGE) | Apr 25, 1989 | Substantially Equivalent | MONAD CORP. |
| K891394 | PM830 ELECTRIC MASSAGER | Apr 10, 1989 | Substantially Equivalent | BACK IN ACTION, INC. |
| K890923 | VITALON MATRESS MASSAGE MODEL M-MX | Mar 14, 1989 | Substantially Equivalent | NEXUS CO. LTD. C/O YAMA TRANS CO. LTD. |
| K890643 | VITALON CHAIR MASSAGER MODEL V-CHR2 | Feb 22, 1989 | Substantially Equivalent | NEXUS CO. LTD. C/O YAMA TRANS CO. LTD. |
| K883064 | MASSAGE MACHINE (CAT. EM-01 ULE 111756) | Aug 23, 1988 | Substantially Equivalent | EMRAD, LTD. |
| K874716 | PULSOR, THERAPEUTIC VIBRATOR | Feb 11, 1988 | Substantially Equivalent | GMG ENTERPRISES, INC. |
| K873819 | MODIFIED STRESS MACHINE | Jan 22, 1988 | Substantially Equivalent | S.J.F., INC. |
| K874843 | VITALON MASSAGER | Jan 20, 1988 | Substantially Equivalent | NEXUS CO. LTD. C/O YAMA TRANS CO. LTD. |
| K873794 | HOT ROD THERMAL MASSAGE ROLLER | Dec 10, 1987 | Substantially Equivalent | AMERICAN PROGRESSIVE PRODUCTS CORP. |
| K872028 | BIRDIE BRACKET | Jul 31, 1987 | Substantially Equivalent | WILLIAM W. WILKERSON & GREGORY A. KNUTSON |
| K870939 | VIBRACARE | Apr 06, 1987 | Substantially Equivalent | GENERAL PHYSIOTHERAPY, INC. |
| K864088 | HITACHI HAND HELD MASSAGER A/C POWERED | Nov 03, 1986 | Substantially Equivalent | HITACHI SALES CORPORATION OF AMERICA |
| K863197 | VIBROFLEX | Sep 19, 1986 | Substantially Equivalent | STOFFREGEN & CO., INC. |
| K863383 | FACIAL MASSAGER, BATTERY POWERED | Sep 15, 1986 | Substantially Equivalent | GENERAL PHYSIOTHERAPY, INC. |
| K862041 | WM10, WM20, WM30 POWER MASSAGER | Jun 17, 1986 | Substantially Equivalent | ASSOCIATED MILLS, INC. |
| K861834 | THERACUSHION MODEL 1000 | May 27, 1986 | Substantially Equivalent | GENERAL PHYSIOTHERAPY, INC. |
| K853710 | THERACUSHION | Jan 03, 1986 | Substantially Equivalent | GENERAL PHYSIOTHERAPY, INC. |
| K853297 | MULTIPLE | Nov 05, 1985 | Substantially Equivalent | SUN AIR, INC. |
| K852944 | FLEXIMATIC MASSAGER | Sep 05, 1985 | Substantially Equivalent | GENERAL PHYSIOTHERAPY, INC. |
| K850851 | G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S | Jun 25, 1985 | Substantially Equivalent | PHYSIO TECHNOLOGY, INC. |
| K850771 | OSTER MASSAGE WAND STICK MASSAGER 295-07 | May 14, 1985 | Substantially Equivalent | DAITO ELECTRIC MACHINE INDUSTRIES COMPANY, LTD. |
| K842802 | VACOMED 4 | Aug 01, 1984 | Substantially Equivalent | ROBERT BOSCH CORP. |
| K840035 | HAYDAY IRRIT-EASER WAND | Jan 30, 1984 | Substantially Equivalent | HAYDAY IRRIT-EASER |
| K833840 | MASSATOR-PEDIO | Nov 29, 1983 | Substantially Equivalent | TRILEEN, INC. |
| K832913 | BACK MASSAGER B-400 ADJUSTABLE | Nov 07, 1983 | Substantially Equivalent | POLLENEX ASSOCIATED MILLS, INC. |
| K833090 | SENSORY ROLLER MASSAGER | Oct 14, 1983 | Substantially Equivalent | MADDAK, INC. |
| K831699 | STRESS MACHINE | Jul 12, 1983 | Substantially Equivalent | DR. WILLIAM F. CURRAN |
| K831206 | ARUBI FLATTER & ARUBI FLATTER-S | Jun 02, 1983 | Substantially Equivalent | KC EXPORT MANAGEMENT CO. |
| K823927 | HIPUSH HANDHELD MASSAGER | Feb 15, 1983 | Substantially Equivalent | NEW AGE CORP. |
| K821109 | TRIMMORE ELECTION BEAUTIFIER | Aug 31, 1982 | Substantially Equivalent | RN INT'L, INC. |
| K811782 | SOFT & STROKE | Jul 31, 1981 | Substantially Equivalent | PHOENIX INTL. MARKETING, INC. |
| K811891 | NORELCO MASSAGER PLUS HEAT BELT | Jul 20, 1981 | Substantially Equivalent | NORTH AMERICAN PHILIPS CORP. |
| K810447 | MAGIC CUSHION MASSAGER | Mar 04, 1981 | Substantially Equivalent | FRED SAMMONS, INC. |
| K810354 | PERCUSS-O-FLEX FOOT & HAND MASSAGER | Feb 23, 1981 | Substantially Equivalent | MODERN REFLEXOLOGY, INC. |
| K801593 | LEBODY BY WATER PIK | Aug 20, 1980 | Substantially Equivalent | TELEDYNE, INC. |
| K780683 | TISSUE PULSATOR | May 03, 1978 | Substantially Equivalent | PULSATOR CORP. |
| K760616 | PROPIOCEPTOR MASSAGER | Jan 13, 1977 | Substantially Equivalent | CELLERS RESEARCH, INC. |
FEI Numbers
This FDA classification entry is associated with 783 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 783 registration numbers. Click on an entry to view related FDA registrations.