K001079 is an FDA 510(k) clearance for the RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO. This device is classified as a Bath, Hydro-massage (Class II - Special Controls, product code ILJ).
Submitted by Arjo, Inc. (Roselle, US). The FDA issued a Cleared decision on May 1, 2000, 27 days after receiving the submission on April 4, 2000.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5100.
| 510(k) Number | K001079 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2000 |
| Decision Date | May 01, 2000 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | ILJ — Bath, Hydro-massage |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5100 |