Vibrator, Therapeutic
FDA product code IRO · Class I (low risk) · 21 CFR 890.5975 · Physical Medicine
65510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Conair Corp. 12
- Fairform Mfg., Co., Ltd. 11
- Fred Sammons, Inc. 5
- Windmere Corp. 3
- Wahl Clipper Corp. 3
- Mcshirley Products, Inc. 2
- Electro Medica Office 1
- East Health Development Group, Inc. 1
- Frank J. Biehl 1
- Jereva, Inc. 1
- Intl. Pacific Industrial Corp. (Usa), Inc. 1
- Sobel Shipping Co., Inc. 1
- Henley Intl. 1
- Wellness Innovations Corp. 1
- Jansson A/S 1
- Weingart, Inc. 1
- North American Philips Corp. 1
- Durham Electric Co. 1
- Eicona Corp. 1
- General Physiotherapy, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955250 | Qi Gong MassagerIRO · Traditional | East Health Development Group, Inc. | 02/08/1996SN |
| K955160 | Comfort, Muscle, Cordless Massager, Battery Powered Operated MassagerIRO · Traditional | Everapex Design & Marketing Corp. | 02/08/1996SN |
| K954203 | Massager Theraputic, ElectricIRO · Traditional | Cisco Sales Corp. | 12/11/1995SN |
| K952916 | Shiatsu Master Massager CushionIRO · Traditional | Kinsei Shiatsu, Inc. | 08/28/1995SN |
| K951414 | Champion Physioacousticc Recliner-Transporter ChairIRO · Traditional | Champion Mfg. Corp. | 08/11/1995SN |
| K950441 | Conair Family Fitness Body EnergyIRO · Traditional | Conair Corp. | 07/18/1995SE |
| K946382 | Skalpi 3200IRO · Traditional | Wiscco Development, Inc. | 05/30/1995SE |
| K950410 | Conair Body and SoleIRO · Traditional | Conair Corp. | 05/23/1995SE |
| K944909 | Wahl Fresh FaceIRO · Traditional | Wahl Clipper Corp. | 05/08/1995SE |
| K950400 | Hand Massage UnitIRO · Traditional | Ultrassage, Inc. | 03/30/1995SE |
| K945603 | Cordless Massager with Heat ( Various Brand Names)IRO · Traditional | Headwaters, Inc. | 02/09/1995SN |
| K940582 | Massaging Helmet C.F. Hansen DesignIRO · Traditional | Philco Ushuaia | 01/30/1995SN |
| K943730 | Squeeze PlayIRO · Traditional | Conair Corp. | 11/28/1994SN |
| K941412 | Wahl Compact Comfort MassagerIRO · Traditional | Wahl Clipper Corp. | 06/09/1994SN |
| K940837 | Wahl(R) Foot Comfort MassagerIRO · Traditional | Wahl Clipper Corp. | 06/09/1994SN |
| K934886 | Next Wave Physioacoustic MattressIRO · Traditional | Next Wave, Inc. | 06/09/1994SN |
| K931640 | AO11 Body MassagerIRO · Traditional | Fairform Mfg., Co., Ltd. | 03/28/1994SE |
| K931639 | F183 Ac-Mini Massager with Ul Aproved AdaptorIRO · Traditional | Fairform Mfg., Co., Ltd. | 03/28/1994SE |
| K931638 | FO96 Handy MassagerIRO · Traditional | Fairform Mfg., Co., Ltd. | 03/28/1994SE |
| K931637 | A013 Femi-Form Facial MassagerIRO · Traditional | Fairform Mfg., Co., Ltd. | 03/28/1994SE |
| K933974 | Windmere Massage MateIRO · Traditional | Windmere Corp. | 02/02/1994SE |
| K923238 | SonassageIRO · Traditional | Conair Corp. | 02/02/1994SE |
| K931819 | Carapace Suture Removal TraysIRO · Traditional | Carapace, Inc. | 01/26/1994SEKD |
| K924584 | Health Essentials Fancy Personal MassagerIRO · Traditional | Conair Corp. | 10/12/1993SE |
| K924583 | Health Essentials Multi-Purpose MassagerIRO · Traditional | Conair Corp. | 10/12/1993SE |
| K924582 | Health Essentials Body Care MassagerIRO · Traditional | Conair Corp. | 10/12/1993SE |
| K924581 | Health Essentials Maxi MassagerIRO · Traditional | Conair Corp. | 10/12/1993SE |
| K924519 | BodythermIRO · Traditional | Conair Corp. | 10/12/1993SE |
| K924431 | Healtlh Essentials Personal MassagerIRO · Traditional | Conair Corp. | 10/12/1993SE |
| K931086 | Windmere Vibra Touch Personal Body MassagerIRO · Traditional | Windmere Corp. | 09/30/1993SE |
| K920487 | Mini VibratorIRO · Traditional | Alimed, Inc. | 02/18/1992SE |
| K913439 | Sonix...Therapeutic Sonic MassageIRO · Traditional | Mcshirley Products, Inc. | 01/22/1992SE |
| K913998 | Pam PlusIRO · Traditional | Kinetic Concepts, Inc. | 01/08/1992SE |
| K915242 | Touch N Tone 1 MassagerIRO · Traditional | Conair Corp. | 12/20/1991SE |
| K914830 | A101 LitessagerIRO · Traditional | Fairform Mfg., Co., Ltd. | 12/09/1991SE |
| K914829 | FO92 Seating MassagerIRO · Traditional | Fairform Mfg., Co., Ltd. | 12/09/1991SE |
| K914707 | F055 B.O. Fantastic RelaxerIRO · Traditional | Fairform Mfg., Co., Ltd. | 12/09/1991SE |
| K914706 | FO51/F151 Golf MassagerIRO · Traditional | Fairform Mfg., Co., Ltd. | 12/09/1991SE |
| K914705 | FO41 Body MassagerIRO · Traditional | Fairform Mfg., Co., Ltd. | 12/09/1991SE |
| K914704 | FO69 Fancy MassagerIRO · Traditional | Fairform Mfg., Co., Ltd. | 12/09/1991SE |
| K914703 | F383 Rechargeable Mini MassagerIRO · Traditional | Fairform Mfg., Co., Ltd. | 12/09/1991SE |
| K914344 | Multi-Reach II Wand MassagerIRO · Traditional | Conair Corp. | 10/24/1991SE |
| K912659 | Sound ReliefIRO · Traditional | Windmere Corp. | 09/06/1991SE |
| K912479 | Motor Massage PillowIRO · Traditional | Supreme Import , Ltd. | 08/09/1991SE |
| K905836 | Ultra Wave 101IRO · Traditional | Ako USA, Inc. | 01/14/1991SE |
| K903098 | Mini-VibratorIRO · Traditional | Frank J. Biehl | 07/25/1990SE |
| K901931 | Leg EezeIRO · Traditional | Jereva, Inc. | 06/14/1990SE |
| K896947 | Chiropractic Massage PillowIRO · Traditional | Intl. Pacific Industrial Corp. (Usa), Inc. | 01/02/1990SE |
| K883913 | La MasseuseIRO · Traditional | Sobel Shipping Co., Inc. | 11/16/1988SE |
| K871107 | Vasotrain 447IRO · Traditional | Henley Intl. | 05/29/1987SN |
| K870972 | Sonafon, Therapeutic MassagerIRO · Traditional | Electro Medica Office | 04/13/1987SE |
| K860159 | Thumper (Vibrator/Massager)IRO · Traditional | Wellness Innovations Corp. | 02/06/1986SE |
| K850495 | Akufon Therapeutic MassagerIRO · Traditional | Jansson A/S | 01/03/1986SE |
| K842379 | Electro-Sage Model 203IRO · Traditional | Weingart, Inc. | 08/10/1984SE |
| K833370 | Linear Vibration a Mcshirley ProductIRO · Traditional | Mcshirley Products, Inc. | 11/28/1983SE |
| K830715 | Norelco Vibrating Board V900IRO · Traditional | North American Philips Corp. | 05/25/1983SE |
| K821133 | Electrical Vibrating DeviceIRO · Traditional | Durham Electric Co. | 07/09/1982SE |
| K821633 | Variable Speed Vibrator, 120V 83-117 VibIRO · Traditional | Fred Sammons, Inc. | 06/11/1982SE |
| K812902 | Acupress VibratorIRO · Traditional | Eicona Corp. | 11/10/1981SE |
| K810446 | VibratorIRO · Traditional | Fred Sammons, Inc. | 03/04/1981SE |
| K810244 | Porta-Puls Muscle StimulatorIRO · Traditional | General Physiotherapy, Inc. | 02/26/1981SE |
| K800250 | HMB-200IRO · Traditional | Associated Mills, Inc. | 03/25/1980SE |
| K800018 | BK-5203 Facilitation Vibrator ElectricIRO · Traditional | Fred Sammons, Inc. | 01/21/1980SE |
| K771279 | Head Facilitation Vibrator BK-5210IRO · Traditional | Fred Sammons, Inc. | 08/26/1977SE |
| K761121 | Electric VibratorIRO · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1820-2012 Class II | USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the…Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain… | Non-Invasive Monitoring Systems, Inc. | 05/07/2012Terminated |
| Z-1819-2012 Class II | US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the…Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain… | Non-Invasive Monitoring Systems, Inc. | 05/07/2012Terminated |