K912179 is an FDA 510(k) clearance for the THE SPRITZ BATH. This device is classified as a Bath, Sitz, Nonpowered (Class I - General Controls, product code KTC).
Submitted by The Spritz Co. (Houston, US). The FDA issued a Cleared decision on August 28, 1991, 104 days after receiving the submission on May 16, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5125.
| 510(k) Number | K912179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1991 |
| Decision Date | August 28, 1991 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | KTC — Bath, Sitz, Nonpowered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5125 |