K841711 is an FDA 510(k) clearance for the MAC LEE SITZ BATH. This device is classified as a Bath, Sitz, Nonpowered (Class I - General Controls, product code KTC).
Submitted by Mac Lee Medical Products (Mchenry, US). The FDA issued a Cleared decision on May 7, 1984, 13 days after receiving the submission on April 24, 1984.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5125.
| 510(k) Number | K841711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 24, 1984 |
| Decision Date | May 07, 1984 |
| Days to Decision | 13 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 |