Body Relaxer
FDA 510(k) K926339 · Conair Corp.
510(k) numberK926339
Submission
- Device name
- Body Relaxer
- Applicant
- Conair Corp.
Stamford, CT, US - Received
- December 15, 1992
- Decision date
- March 4, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ISA – Massager, Therapeutic, Electric
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5660
- Specialty
- Physical Medicine
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| K942950 | Body FlexISA · Traditional | 07/26/1994SN |
| K942223 | Body SystemISA · Traditional | 06/09/1994SN |
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Questions and answers
When was Body Relaxer cleared by the FDA?
Body Relaxer (K926339) received a 510(k) decision of Substantially Equivalent on March 4, 1994, 444 days after the submission was received.
What is the product code of K926339?
The FDA product code is ISA – Massager, Therapeutic, Electric, a Class I (low risk) device regulated under 21 CFR 890.5660.