K895477 is an FDA 510(k) clearance for the NOVA PILLOW. This device is classified as a Orthosis, Cervical (Class I - General Controls, product code IQK).
Submitted by Nova Health Systems, Inc. (Blackwood, US). The FDA issued a Cleared decision on January 10, 1990, 121 days after receiving the submission on September 11, 1989.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K895477 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1989 |
| Decision Date | January 10, 1990 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IQK — Orthosis, Cervical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3490 |