Atlas FDA

ISA

100 FDA 510(k) clearances · Product code

86 daysmedian time to decision
380 days90th percentile
100clearances measured

FDA profile

Official device name
Massager, Therapeutic, Electric
Device class
Class I (low risk)
Regulation
21 CFR 890.5660
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2007: 2 · 2008: 10 · 2009: 3 · 2014: 6 · 2016: 12 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
VMAT PRO (K243488)Termosalud2025-02-06
ShockPhysio Mobile (model SW3200 Basic) (K240358)Shenzhen Dongdixin Technology Co., Ltd.2024-06-05
BTL-094 (K221865)BTL Industries, Inc.2023-04-14
Omnispec ED1000 (K210166)Medispec, Ltd.2023-01-27
OW100S (model OW100S-US) (K213120)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt2022-10-12
DolorClast Radial (K220538)E.M.S Electro Medical Systems S.A2022-07-11
OrthoGold 100 (K210451)Tissue Regeneration Technologies, LLC2021-05-05
OrthoGold 100 (K182682)Tissue Regeneration Technologies2018-12-21
D-Actor 200 Vibration Massage System (K173692)Storz Medical AG2018-04-13
CELLU M6 KEYMODULE I (K053225)Lpg One, Inc.2006-11-06
CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM (K030876)Cynosure, Inc.2004-01-22
JET THERAPY (K002908)Jet Therapy2001-08-30
LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR (K990445)Lpg USA, Inc.2000-01-18
SPIN ROLLERE (K952990)Kinsei Shiatsu, Inc.1995-09-29
BODYFLEX MASSAGER (K952041)Truro'S Ent.1995-08-14
RELAXU-1 (K950411)Kinsei Shiatsu, Inc.1995-08-02
AVON MASSAGING HAIRBRUSH (K950931)Siegel,Mandell & Davidson,P.C.1995-04-05
THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES (K950655)Ultrassage, Inc.1995-03-07
SHAPE UP MOMI ROLLER (K950321)Kinsei Shiatsu, Inc.1995-02-14
DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000 (K944885)Kolvin Industries , Ltd.1995-02-14
MASSAGER (K944730)North American Technical Services Corp.1995-02-14
RELAXY-THE WONDER HAND (K950322)Kinsei Shiatsu, Inc.1995-02-14
RELAXY-WONDER KNOCK (K950320)Kinsei Shiatsu, Inc.1995-02-14
DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B (K944884)Kolvin Industries , Ltd.1995-02-14
AGILANCE-GOLDEN SPOONS (K936178)Oismuller & Partner Keg1995-01-18
FAMILY FITNESS SHIATSU MASSAGER (K944637)Conair Corp.1994-12-13
STIMU-TAP (K944024)Wahl Clipper Corp.1994-12-08
FAMILY FITNESS SHIATSU MASSAGER (K943092)Conair Corp.1994-09-29
BODY FLEX (K942950)Conair Corp.1994-07-26
PRO-SHIATSU PORTABLE MASSAGER (K940621)Westminster International Co., Inc.1994-06-22
SHIATSU MASSAGER (K942218)Westminster International Co., Inc.1994-06-22
BODY SYSTEM (K942223)Conair Corp.1994-06-09
WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA (K940683)Wahl Clipper Corp.1994-06-09
WAHL DOUBLE COMFORT MASSAGER (K941594)Wahl Clipper Corp.1994-06-09
MODEL 777 THERAPEUTIC MASSAGER (K940543)Voyager Medical Corp.1994-04-21
BODY RECHARGER (K940369)Conair Corp.1994-04-21
AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER (K925907)Pollenex Corp.1994-03-30
FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER (K931636)Fairform Mfg., Co., Ltd.1994-03-28
OMBRON TWIN-HEAD MASSAGER MODEL HM-101 (K935462)Omron Healthcare, Inc.1994-03-04
BODY RELAXER (K926339)Conair Corp.1994-03-04
OMRON MASSAGER MODEL HM-102 (K935581)Omron Healthcare, Inc.1994-03-04
OMRON MASSAGER MODEL HM-45 (K935459)Omron Healthcare, Inc.1994-03-04
INFRADERM; TOUCH 'N TONE PLUS (K911727)Conair Corp.1994-02-25
WINDMERE WAND MASSAGER (K932904)Windmere Corp.1994-02-17
WINDMERE PRELUDE III (K924237)Windmere Corp.1993-10-18
BODY SOOTHER (K924518)Conair Corp.1993-10-12
BODY TRAINER (K924520)Conair Corp.1993-09-30
HANDY VIBRO BELT (K925036)Cosmesearch, Inc.1993-06-29
BODY-MATE MASSAGER (K923541)American Therapy Products1993-06-24
SONACARE SOUND MASSAGER (K921000)Honor Trading, Ltd.1993-03-31
AUQASOOTHE/AQUA MED (K915729)Aquasoothe1992-04-29
AQUA MED (K914943)Aqua Massage Intl., Inc.1992-04-02
PERSONAL BODY MASSAGER, MODELS 1605 & 1606 (K912822)Raymond Industrial, Ltd.1992-02-11
VIBRATOUCH II CORDLESS WAND MASSAGER (K912383)Conair Corp.1991-10-07
CORDLESS ELECTRIC MASSAGER EV315 (K912634)Matsushita Electric Co.1991-09-12
GOOD VIBRATIONS TUBE MASSAGER (K910519)Dual Voltage, Inc.1991-04-01
CARESS MASSAGER (K904915)Kendex Corp.1990-11-27
MUSCLE MASSAGER (K903617)Uri Halfon and Gabriel Hertzberg1990-11-26
QI-GONG MACHINE THERAPEUTIC MASSAGER (K904242)China Healthways Institute1990-10-11
PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE (K901796)Component Equipment Mfg., Inc.1990-06-06
CONSTI-SSAGE VIBRATOR/MASSAGE (K900674)Bio-Tech Co.1990-03-02
OMRON TRAVEL MASSAGER, MODEL HM-01 (K893029)Omron Electronics, Inc.1989-05-31
COMFORTRAC, CT90 & CT100 BI-PHASICS (K892669)Comfortrac Systems1989-05-26
PHASER (SINGLE LINEAR MECHANICAL MASSAGE) (K891871)Monad Corp.1989-04-25
PM830 ELECTRIC MASSAGER (K891394)Back IN Action, Inc.1989-04-10
VITALON MATRESS MASSAGE MODEL M-MX (K890923)Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.1989-03-14
VITALON CHAIR MASSAGER MODEL V-CHR2 (K890643)Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.1989-02-22
MASSAGE MACHINE (CAT. EM-01 ULE 111756) (K883064)Emrad, Ltd.1988-08-23
PULSOR, THERAPEUTIC VIBRATOR (K874716)Gmg Enterprises, Inc.1988-02-11
MODIFIED STRESS MACHINE (K873819)S.J.F., Inc.1988-01-22
VITALON MASSAGER (K874843)Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.1988-01-20
HOT ROD THERMAL MASSAGE ROLLER (K873794)American Progressive Products Corp.1987-12-10
BIRDIE BRACKET (K872028)William W. Wilkerson & Gregory A. Knutson1987-07-31
VIBRACARE (K870939)General Physiotherapy, Inc.1987-04-06
HITACHI HAND HELD MASSAGER A/C POWERED (K864088)Hitachi Sales Corporation of America1986-11-03
VIBROFLEX (K863197)Stoffregen & Co., Inc.1986-09-19
FACIAL MASSAGER, BATTERY POWERED (K863383)General Physiotherapy, Inc.1986-09-15
WM10, WM20, WM30 POWER MASSAGER (K862041)Associated Mills, Inc.1986-06-17
THERACUSHION MODEL 1000 (K861834)General Physiotherapy, Inc.1986-05-27
THERACUSHION (K853710)General Physiotherapy, Inc.1986-01-03
MULTIPLE (K853297)Sun Air, Inc.1985-11-05
FLEXIMATIC MASSAGER (K852944)General Physiotherapy, Inc.1985-09-05
G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S (K850851)Physio Technology, Inc.1985-06-25
OSTER MASSAGE WAND STICK MASSAGER 295-07 (K850771)Daito Electric Machine Industries Company, Ltd.1985-05-14
VACOMED 4 (K842802)Robert Bosch Corp.1984-08-01
HAYDAY IRRIT-EASER WAND (K840035)Hayday Irrit-Easer1984-01-30
MASSATOR-PEDIO (K833840)Trileen, Inc.1983-11-29
BACK MASSAGER B-400 ADJUSTABLE (K832913)Pollenex Associated Mills, Inc.1983-11-07
SENSORY ROLLER MASSAGER (K833090)Maddak, Inc.1983-10-14
STRESS MACHINE (K831699)Dr. William F. Curran1983-07-12
ARUBI FLATTER & ARUBI FLATTER-S (K831206)Kc Export Management Co.1983-06-02
HIPUSH HANDHELD MASSAGER (K823927)New Age Corp.1983-02-15
TRIMMORE ELECTION BEAUTIFIER (K821109)Rn Int'L, Inc.1982-08-31
SOFT & STROKE (K811782)Phoenix Intl. Marketing, Inc.1981-07-31
NORELCO MASSAGER PLUS HEAT BELT (K811891)North American Philips Corp.1981-07-20
MAGIC CUSHION MASSAGER (K810447)Fred Sammons, Inc.1981-03-04
PERCUSS-O-FLEX FOOT & HAND MASSAGER (K810354)Modern Reflexology, Inc.1981-02-23
LEBODY BY WATER PIK (K801593)Teledyne, Inc.1980-08-20
TISSUE PULSATOR (K780683)Pulsator Corp.1978-05-03
PROPIOCEPTOR MASSAGER (K760616)Cellers Research, Inc.1977-01-13

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