Conair Body and Sole
FDA 510(k) K950410 · Conair Corp.
510(k) numberK950410
Submission
- Device name
- Conair Body and Sole
- Applicant
- Conair Corp.
Stamford, CT, US - Received
- January 31, 1995
- Decision date
- May 23, 1995
- 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 |
| 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 |
More from Headwaters, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172791 | Lumilisse IPL Hair RemoverOHT · Traditional | 01/18/2018SE |
| K950441 | Conair Family Fitness Body EnergyIRO · Traditional | 07/18/1995SE |
| K944637 | Family Fitness Shiatsu MassagerISA · Traditional | 12/13/1994SN |
| K943730 | Squeeze PlayIRO · Traditional | 11/28/1994SN |
| K924970 | Feminine Heat WrapIRT · Traditional | 10/03/1994SN |
| K943092 | Family Fitness Shiatsu MassagerISA · Traditional | 09/29/1994SE |
| K942950 | Body FlexISA · Traditional | 07/26/1994SN |
| K942223 | Body SystemISA · Traditional | 06/09/1994SN |
| K940369 | Body RechargerISA · Traditional | 04/21/1994SN |
| K926339 | Body RelaxerISA · Traditional | 03/04/1994SE |
Questions and answers
When was Conair Body and Sole cleared by the FDA?
Conair Body and Sole (K950410) received a 510(k) decision of Substantially Equivalent on May 23, 1995, 112 days after the submission was received.
What is the product code of K950410?
The FDA product code is IRO – Vibrator, Therapeutic, a Class I (low risk) device regulated under 21 CFR 890.5975.