K912822 is an FDA 510(k) clearance for the PERSONAL BODY MASSAGER, MODELS 1605 & 1606. This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by Raymond Industrial, Ltd. (Norwalk, US). The FDA issued a Cleared decision on February 11, 1992, 231 days after receiving the submission on June 25, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K912822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1991 |
| Decision Date | February 11, 1992 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | ISA — Massager, Therapeutic, Electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5660 |