Atlas FDA

IRO

65 FDA 510(k) clearances · Product code

78 daysmedian time to decision
397 days90th percentile
65clearances measured

FDA profile

Official device name
Vibrator, Therapeutic
Device class
Class I (low risk)
Regulation
21 CFR 890.5975
Medical specialty
Physical Medicine
Adverse events (MAUDE)
1994: 1 · 1996: 1 · 1998: 1
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
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER (K955160)Everapex Design & Marketing Corp.1996-02-08
QI GONG MASSAGER (K955250)East Health Development Group, Inc.1996-02-08
MASSAGER THERAPUTIC, ELECTRIC (K954203)Cisco Sales Corp.1995-12-11
SHIATSU MASTER MASSAGER CUSHION (K952916)Kinsei Shiatsu, Inc.1995-08-28
CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR (K951414)Champion Mfg. Corp.1995-08-11
CONAIR FAMILY FITNESS BODY ENERGY (K950441)Conair Corp.1995-07-18
SKALPI 3200 (K946382)Wiscco Development, Inc.1995-05-30
CONAIR BODY AND SOLE (K950410)Conair Corp.1995-05-23
WAHL FRESH FACE (K944909)Wahl Clipper Corp.1995-05-08
HAND MASSAGE UNIT (K950400)Ultrassage, Inc.1995-03-30
CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES) (K945603)Headwaters, Inc.1995-02-09
MASSAGING HELMET C.F. HANSEN DESIGN (K940582)Philco Ushuaia1995-01-30
SQUEEZE PLAY (K943730)Conair Corp.1994-11-28
WAHL COMPACT COMFORT MASSAGER (K941412)Wahl Clipper Corp.1994-06-09
NEXT WAVE PHYSIOACOUSTIC MATTRESS (K934886)Next Wave, Inc.1994-06-09
WAHL(R) FOOT COMFORT MASSAGER (K940837)Wahl Clipper Corp.1994-06-09
A013 FEMI-FORM FACIAL MASSAGER (K931637)Fairform Mfg., Co., Ltd.1994-03-28
FO96 HANDY MASSAGER (K931638)Fairform Mfg., Co., Ltd.1994-03-28
F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR (K931639)Fairform Mfg., Co., Ltd.1994-03-28
AO11 BODY MASSAGER (K931640)Fairform Mfg., Co., Ltd.1994-03-28
SONASSAGE (K923238)Conair Corp.1994-02-02
WINDMERE MASSAGE MATE (K933974)Windmere Corp.1994-02-02
CARAPACE SUTURE REMOVAL TRAYS (K931819)Carapace, Inc.1994-01-26
HEALTH ESSENTIALS MAXI MASSAGER (K924581)Conair Corp.1993-10-12
HEALTH ESSENTIALS BODY CARE MASSAGER (K924582)Conair Corp.1993-10-12
HEALTH ESSENTIALS FANCY PERSONAL MASSAGER (K924584)Conair Corp.1993-10-12
BODYTHERM (K924519)Conair Corp.1993-10-12
HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER (K924583)Conair Corp.1993-10-12
HEALTLH ESSENTIALS PERSONAL MASSAGER (K924431)Conair Corp.1993-10-12
WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER (K931086)Windmere Corp.1993-09-30
MINI VIBRATOR (K920487)Alimed, Inc.1992-02-18
SONIX...THERAPEUTIC SONIC MASSAGE (K913439)Mcshirley Products, Inc.1992-01-22
PAM PLUS (K913998)Kinetic Concepts, Inc.1992-01-08
TOUCH N TONE 1 MASSAGER (K915242)Conair Corp.1991-12-20
F055 B.O. FANTASTIC RELAXER (K914707)Fairform Mfg., Co., Ltd.1991-12-09
F383 RECHARGEABLE MINI MASSAGER (K914703)Fairform Mfg., Co., Ltd.1991-12-09
A101 LITESSAGER (K914830)Fairform Mfg., Co., Ltd.1991-12-09
FO92 SEATING MASSAGER (K914829)Fairform Mfg., Co., Ltd.1991-12-09
FO69 FANCY MASSAGER (K914704)Fairform Mfg., Co., Ltd.1991-12-09
FO51/F151 GOLF MASSAGER (K914706)Fairform Mfg., Co., Ltd.1991-12-09
FO41 BODY MASSAGER (K914705)Fairform Mfg., Co., Ltd.1991-12-09
MULTI-REACH II WAND MASSAGER (K914344)Conair Corp.1991-10-24
SOUND RELIEF (K912659)Windmere Corp.1991-09-06
MOTOR MASSAGE PILLOW (K912479)Supreme Import , Ltd.1991-08-09
ULTRA WAVE 101 (K905836)Ako USA, Inc.1991-01-14
MINI-VIBRATOR (K903098)Frank J. Biehl1990-07-25
LEG EEZE (K901931)Jereva, Inc.1990-06-14
CHIROPRACTIC MASSAGE PILLOW (K896947)Intl. Pacific Industrial Corp. (Usa), Inc.1990-01-02
LA MASSEUSE (K883913)Sobel Shipping Co., Inc.1988-11-16
VASOTRAIN 447 (K871107)Henley Intl.1987-05-29
SONAFON, THERAPEUTIC MASSAGER (K870972)Electro Medica Office1987-04-13
THUMPER (VIBRATOR/MASSAGER) (K860159)Wellness Innovations Corp.1986-02-06
AKUFON THERAPEUTIC MASSAGER (K850495)Jansson A/S1986-01-03
ELECTRO-SAGE MODEL 203 (K842379)Weingart, Inc.1984-08-10
LINEAR VIBRATION A MCSHIRLEY PRODUCT (K833370)Mcshirley Products, Inc.1983-11-28
NORELCO VIBRATING BOARD V900 (K830715)North American Philips Corp.1983-05-25
ELECTRICAL VIBRATING DEVICE (K821133)Durham Electric Co.1982-07-09
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB (K821633)Fred Sammons, Inc.1982-06-11
ACUPRESS VIBRATOR (K812902)Eicona Corp.1981-11-10
VIBRATOR (K810446)Fred Sammons, Inc.1981-03-04
PORTA-PULS MUSCLE STIMULATOR (K810244)General Physiotherapy, Inc.1981-02-26
HMB-200 (K800250)Associated Mills, Inc.1980-03-25
BK-5203 FACILITATION VIBRATOR ELECTRIC (K800018)Fred Sammons, Inc.1980-01-21
HEAD FACILITATION VIBRATOR BK-5210 (K771279)Fred Sammons, Inc.1977-08-26
ELECTRIC VIBRATOR (K761121)Fred Sammons, Inc.1976-12-02

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