K972176 is an FDA 510(k) clearance for the HOME CARE BEAD BED. This device is classified as a Bed, Air Fluidized (Class II - Special Controls, product code INX).
Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on January 16, 1998, 221 days after receiving the submission on June 9, 1997.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5160.
| 510(k) Number | K972176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1997 |
| Decision Date | January 16, 1998 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INX — Bed, Air Fluidized |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5160 |