K831762 is an FDA 510(k) clearance for the SITZ BATH, SINGLE PATIENT USE #8100. This device is classified as a Bath, Sitz, Nonpowered (Class I - General Controls, product code KTC).
Submitted by Lsl Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983, 23 days after receiving the submission on June 1, 1983.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5125.
| 510(k) Number | K831762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1983 |
| Decision Date | June 24, 1983 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | KTC — Bath, Sitz, Nonpowered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5125 |