A013 Femi-Form Facial Massager
FDA 510(k) K931637 · Fairform Mfg., Co., Ltd.
510(k) numberK931637
Submission
- Device name
- A013 Femi-Form Facial Massager
- Applicant
- Fairform Mfg., Co., Ltd.
San Po Kong, Kowloon, HK - Received
- March 31, 1993
- Decision date
- March 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IRO – Vibrator, Therapeutic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5975
- Specialty
- Physical Medicine
Other 510(k)s with product code IRO
| 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 |
More from Ultrassage, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931640 | AO11 Body MassagerIRO · Traditional | 03/28/1994SE |
| K931639 | F183 Ac-Mini Massager with Ul Aproved AdaptorIRO · Traditional | 03/28/1994SE |
| K931638 | FO96 Handy MassagerIRO · Traditional | 03/28/1994SE |
| K931636 | FO18/FO98 Scruboflex Showerproof Brush MassagerISA · Traditional | 03/28/1994SE |
| K920644 | F499 Deluxe Electric Tooth Brush W/ StandJEQ · Traditional | 05/29/1992SE |
| K914830 | A101 LitessagerIRO · Traditional | 12/09/1991SE |
| K914829 | FO92 Seating MassagerIRO · Traditional | 12/09/1991SE |
| K914707 | F055 B.O. Fantastic RelaxerIRO · Traditional | 12/09/1991SE |
| K914706 | FO51/F151 Golf MassagerIRO · Traditional | 12/09/1991SE |
| K914705 | FO41 Body MassagerIRO · Traditional | 12/09/1991SE |
Questions and answers
When was A013 Femi-Form Facial Massager cleared by the FDA?
A013 Femi-Form Facial Massager (K931637) received a 510(k) decision of Substantially Equivalent on March 28, 1994, 362 days after the submission was received.
What is the product code of K931637?
The FDA product code is IRO – Vibrator, Therapeutic, a Class I (low risk) device regulated under 21 CFR 890.5975.