FDA Product Code
FDA Product Code ISA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5660
510(k) Clearances — 100 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243488 | VMAT PRO | Termosalud | 2025-02-06 | Traditional | PDF ↗ |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | Shenzhen Dongdixin Technology Co., Ltd. | 2024-06-05 | Traditional | PDF ↗ |
| K221865 | BTL-094 | BTL Industries, Inc. | 2023-04-14 | Traditional | PDF ↗ |
| K210166 | Omnispec ED1000 | Medispec, Ltd. | 2023-01-27 | Traditional | PDF ↗ |
| K213120 | OW100S (model OW100S-US) | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | 2022-10-12 | Traditional | PDF ↗ |
| K220538 | DolorClast Radial | E.M.S Electro Medical Systems S.A | 2022-07-11 | Traditional | PDF ↗ |
| K210451 | OrthoGold 100 | Tissue Regeneration Technologies, LLC | 2021-05-05 | Traditional | PDF ↗ |
| K182682 | OrthoGold 100 | Tissue Regeneration Technologies | 2018-12-21 | Traditional | PDF ↗ |
| K173692 | D-Actor 200 Vibration Massage System | Storz Medical AG | 2018-04-13 | Traditional | PDF ↗ |
| K053225 | CELLU M6 KEYMODULE I | Lpg One, Inc. | 2006-11-06 | Traditional | PDF ↗ |
| K030876 | CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM | Cynosure, Inc. | 2004-01-22 | Traditional | PDF ↗ |
| K002908 | JET THERAPY | Jet Therapy | 2001-08-30 | Traditional | PDF ↗ |
| K990445 | LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR | Lpg USA, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K952990 | SPIN ROLLERE | Kinsei Shiatsu, Inc. | 1995-09-29 | Traditional | PDF ↗ |
| K952041 | BODYFLEX MASSAGER | Truro'S Ent. | 1995-08-14 | Traditional | PDF ↗ |
| K950411 | RELAXU-1 | Kinsei Shiatsu, Inc. | 1995-08-02 | Traditional | PDF ↗ |
| K950931 | AVON MASSAGING HAIRBRUSH | Siegel,Mandell & Davidson,P.C. | 1995-04-05 | Traditional | PDF ↗ |
| K950655 | THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES | Ultrassage, Inc. | 1995-03-07 | Traditional | PDF ↗ |
| K950320 | RELAXY-WONDER KNOCK | Kinsei Shiatsu, Inc. | 1995-02-14 | Traditional | PDF ↗ |
| K950322 | RELAXY-THE WONDER HAND | Kinsei Shiatsu, Inc. | 1995-02-14 | Traditional | PDF ↗ |
| K950321 | SHAPE UP MOMI ROLLER | Kinsei Shiatsu, Inc. | 1995-02-14 | Traditional | PDF ↗ |
| K944884 | DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B | Kolvin Industries , Ltd. | 1995-02-14 | Traditional | PDF ↗ |
| 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 | Kolvin Industries , Ltd. | 1995-02-14 | Traditional | PDF ↗ |
| K944730 | MASSAGER | North American Technical Services Corp. | 1995-02-14 | Traditional | PDF ↗ |
| K936178 | AGILANCE-GOLDEN SPOONS | Oismuller & Partner Keg | 1995-01-18 | Traditional | PDF ↗ |
| K944637 | FAMILY FITNESS SHIATSU MASSAGER | Conair Corp. | 1994-12-13 | Traditional | PDF ↗ |
| K944024 | STIMU-TAP | Wahl Clipper Corp. | 1994-12-08 | Traditional | PDF ↗ |
| K943092 | FAMILY FITNESS SHIATSU MASSAGER | Conair Corp. | 1994-09-29 | Traditional | PDF ↗ |
| K942950 | BODY FLEX | Conair Corp. | 1994-07-26 | Traditional | PDF ↗ |
| K940621 | PRO-SHIATSU PORTABLE MASSAGER | Westminster International Co., Inc. | 1994-06-22 | Traditional | PDF ↗ |
| K942218 | SHIATSU MASSAGER | Westminster International Co., Inc. | 1994-06-22 | Traditional | PDF ↗ |
| K940683 | WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA | Wahl Clipper Corp. | 1994-06-09 | Traditional | PDF ↗ |
| K942223 | BODY SYSTEM | Conair Corp. | 1994-06-09 | Traditional | PDF ↗ |
| K941594 | WAHL DOUBLE COMFORT MASSAGER | Wahl Clipper Corp. | 1994-06-09 | Traditional | PDF ↗ |
| K940543 | MODEL 777 THERAPEUTIC MASSAGER | Voyager Medical Corp. | 1994-04-21 | Traditional | PDF ↗ |
| K940369 | BODY RECHARGER | Conair Corp. | 1994-04-21 | Traditional | PDF ↗ |
| K925907 | AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER | Pollenex Corp. | 1994-03-30 | Traditional | PDF ↗ |
| K931636 | FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER | Fairform Mfg., Co., Ltd. | 1994-03-28 | Traditional | PDF ↗ |
| K935462 | OMBRON TWIN-HEAD MASSAGER MODEL HM-101 | Omron Healthcare, Inc. | 1994-03-04 | Traditional | PDF ↗ |
| K926339 | BODY RELAXER | Conair Corp. | 1994-03-04 | Traditional | PDF ↗ |
| K935459 | OMRON MASSAGER MODEL HM-45 | Omron Healthcare, Inc. | 1994-03-04 | Traditional | PDF ↗ |
| K935581 | OMRON MASSAGER MODEL HM-102 | Omron Healthcare, Inc. | 1994-03-04 | Traditional | PDF ↗ |
| K911727 | INFRADERM; TOUCH 'N TONE PLUS | Conair Corp. | 1994-02-25 | Traditional | PDF ↗ |
| K932904 | WINDMERE WAND MASSAGER | Windmere Corp. | 1994-02-17 | Traditional | PDF ↗ |
| K924237 | WINDMERE PRELUDE III | Windmere Corp. | 1993-10-18 | Traditional | PDF ↗ |
| K924518 | BODY SOOTHER | Conair Corp. | 1993-10-12 | Traditional | PDF ↗ |
| K924520 | BODY TRAINER | Conair Corp. | 1993-09-30 | Traditional | PDF ↗ |
| K925036 | HANDY VIBRO BELT | Cosmesearch, Inc. | 1993-06-29 | Traditional | PDF ↗ |
| K923541 | BODY-MATE MASSAGER | American Therapy Products | 1993-06-24 | Traditional | PDF ↗ |
| K921000 | SONACARE SOUND MASSAGER | Honor Trading, Ltd. | 1993-03-31 | Traditional | PDF ↗ |
| K915729 | AUQASOOTHE/AQUA MED | Aquasoothe | 1992-04-29 | Traditional | PDF ↗ |
| K914943 | AQUA MED | Aqua Massage Intl., Inc. | 1992-04-02 | Traditional | PDF ↗ |
| K912822 | PERSONAL BODY MASSAGER, MODELS 1605 & 1606 | Raymond Industrial, Ltd. | 1992-02-11 | Traditional | PDF ↗ |
| K912383 | VIBRATOUCH II CORDLESS WAND MASSAGER | Conair Corp. | 1991-10-07 | Traditional | PDF ↗ |
| K912634 | CORDLESS ELECTRIC MASSAGER EV315 | Matsushita Electric Co. | 1991-09-12 | Traditional | PDF ↗ |
| K910519 | GOOD VIBRATIONS TUBE MASSAGER | Dual Voltage, Inc. | 1991-04-01 | Traditional | PDF ↗ |
| K904915 | CARESS MASSAGER | Kendex Corp. | 1990-11-27 | Traditional | PDF ↗ |
| K903617 | MUSCLE MASSAGER | Uri Halfon and Gabriel Hertzberg | 1990-11-26 | Traditional | PDF ↗ |
| K904242 | QI-GONG MACHINE THERAPEUTIC MASSAGER | China Healthways Institute | 1990-10-11 | Traditional | PDF ↗ |
| K901796 | PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE | Component Equipment Mfg., Inc. | 1990-06-06 | Traditional | PDF ↗ |
| K900674 | CONSTI-SSAGE VIBRATOR/MASSAGE | Bio-Tech Co. | 1990-03-02 | Traditional | PDF ↗ |
| K893029 | OMRON TRAVEL MASSAGER, MODEL HM-01 | Omron Electronics, Inc. | 1989-05-31 | Traditional | PDF ↗ |
| K892669 | COMFORTRAC, CT90 & CT100 BI-PHASICS | Comfortrac Systems | 1989-05-26 | Traditional | PDF ↗ |
| K891871 | PHASER (SINGLE LINEAR MECHANICAL MASSAGE) | Monad Corp. | 1989-04-25 | Traditional | PDF ↗ |
| K891394 | PM830 ELECTRIC MASSAGER | Back IN Action, Inc. | 1989-04-10 | Traditional | PDF ↗ |
| K890923 | VITALON MATRESS MASSAGE MODEL M-MX | Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. | 1989-03-14 | Traditional | PDF ↗ |
| K890643 | VITALON CHAIR MASSAGER MODEL V-CHR2 | Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. | 1989-02-22 | Traditional | PDF ↗ |
| K883064 | MASSAGE MACHINE (CAT. EM-01 ULE 111756) | Emrad, Ltd. | 1988-08-23 | Traditional | PDF ↗ |
| K874716 | PULSOR, THERAPEUTIC VIBRATOR | Gmg Enterprises, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K873819 | MODIFIED STRESS MACHINE | S.J.F., Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K874843 | VITALON MASSAGER | Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. | 1988-01-20 | Traditional | PDF ↗ |
| K873794 | HOT ROD THERMAL MASSAGE ROLLER | American Progressive Products Corp. | 1987-12-10 | Traditional | PDF ↗ |
| K872028 | BIRDIE BRACKET | William W. Wilkerson & Gregory A. Knutson | 1987-07-31 | Traditional | PDF ↗ |
| K870939 | VIBRACARE | General Physiotherapy, Inc. | 1987-04-06 | Traditional | PDF ↗ |
| K864088 | HITACHI HAND HELD MASSAGER A/C POWERED | Hitachi Sales Corporation of America | 1986-11-03 | Traditional | PDF ↗ |
| K863197 | VIBROFLEX | Stoffregen & Co., Inc. | 1986-09-19 | Traditional | PDF ↗ |
| K863383 | FACIAL MASSAGER, BATTERY POWERED | General Physiotherapy, Inc. | 1986-09-15 | Traditional | PDF ↗ |
| K862041 | WM10, WM20, WM30 POWER MASSAGER | Associated Mills, Inc. | 1986-06-17 | Traditional | PDF ↗ |
| K861834 | THERACUSHION MODEL 1000 | General Physiotherapy, Inc. | 1986-05-27 | Traditional | PDF ↗ |
| K853710 | THERACUSHION | General Physiotherapy, Inc. | 1986-01-03 | Traditional | PDF ↗ |
| K853297 | MULTIPLE | Sun Air, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K852944 | FLEXIMATIC MASSAGER | General Physiotherapy, Inc. | 1985-09-05 | Traditional | PDF ↗ |
| K850851 | G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S | Physio Technology, Inc. | 1985-06-25 | Traditional | PDF ↗ |
| K850771 | OSTER MASSAGE WAND STICK MASSAGER 295-07 | Daito Electric Machine Industries Company, Ltd. | 1985-05-14 | Traditional | PDF ↗ |
| K842802 | VACOMED 4 | Robert Bosch Corp. | 1984-08-01 | Traditional | PDF ↗ |
| K840035 | HAYDAY IRRIT-EASER WAND | Hayday Irrit-Easer | 1984-01-30 | Traditional | PDF ↗ |
| K833840 | MASSATOR-PEDIO | Trileen, Inc. | 1983-11-29 | Traditional | PDF ↗ |
| K832913 | BACK MASSAGER B-400 ADJUSTABLE | Pollenex Associated Mills, Inc. | 1983-11-07 | Traditional | PDF ↗ |
| K833090 | SENSORY ROLLER MASSAGER | Maddak, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K831699 | STRESS MACHINE | Dr. William F. Curran | 1983-07-12 | Traditional | PDF ↗ |
| K831206 | ARUBI FLATTER & ARUBI FLATTER-S | Kc Export Management Co. | 1983-06-02 | Traditional | PDF ↗ |
| K823927 | HIPUSH HANDHELD MASSAGER | New Age Corp. | 1983-02-15 | Traditional | PDF ↗ |
| K821109 | TRIMMORE ELECTION BEAUTIFIER | Rn Int'L, Inc. | 1982-08-31 | Traditional | PDF ↗ |
| K811782 | SOFT & STROKE | Phoenix Intl. Marketing, Inc. | 1981-07-31 | Traditional | PDF ↗ |
| K811891 | NORELCO MASSAGER PLUS HEAT BELT | North American Philips Corp. | 1981-07-20 | Traditional | PDF ↗ |
| K810447 | MAGIC CUSHION MASSAGER | Fred Sammons, Inc. | 1981-03-04 | Traditional | PDF ↗ |
| K810354 | PERCUSS-O-FLEX FOOT & HAND MASSAGER | Modern Reflexology, Inc. | 1981-02-23 | Traditional | PDF ↗ |
| K801593 | LEBODY BY WATER PIK | Teledyne, Inc. | 1980-08-20 | Traditional | PDF ↗ |
| K780683 | TISSUE PULSATOR | Pulsator Corp. | 1978-05-03 | Traditional | PDF ↗ |
| K760616 | PROPIOCEPTOR MASSAGER | Cellers Research, Inc. | 1977-01-13 | Traditional | PDF ↗ |
Product code ISA · Class I · Physical Medicine. Data: openFDA.