K914125 is an FDA 510(k) clearance for the FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403. This device is classified as a Bath, Hydro-massage (Class II - Special Controls, product code ILJ).
Submitted by Ferno (Wilmington, US). The FDA issued a Cleared decision on October 25, 1991, 42 days after receiving the submission on September 13, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5100.
| 510(k) Number | K914125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1991 |
| Decision Date | October 25, 1991 |
| Days to Decision | 42 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 |