Product Code: IRO FDA class 1 21 CFR 890.5975

Vibrator, Therapeutic

Physical Medicine

A therapeutic vibrator is an electrically powered device that applies mechanical vibration to soft tissues for therapeutic purposes such as pain relief, muscle relaxation, and improvement of local circulation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IRO, regulated under 21 CFR 890.5975, within the Physical Medicine medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: IRO
Device Class: FDA class 1
Regulation Number: 890.5975
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 65 510(k) clearances via K numbers.

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