K935462 is an FDA 510(k) clearance for the OMBRON TWIN-HEAD MASSAGER MODEL HM-101. This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by Omron Healthcare, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on March 4, 1994, 112 days after receiving the submission on November 12, 1993.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K935462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1993 |
| Decision Date | March 04, 1994 |
| Days to Decision | 112 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 |