K853163 is an FDA 510(k) clearance for the SETMA VHT. This device is classified as a Bath, Hydro-massage (Class II - Special Controls, product code ILJ).
Submitted by Setma, Inc. (Whitehouse, US). The FDA issued a Cleared decision on November 5, 1985, 98 days after receiving the submission on July 30, 1985.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5100.
| 510(k) Number | K853163 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1985 |
| Decision Date | November 05, 1985 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILJ — Bath, Hydro-massage |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5100 |