K961426 is an FDA 510(k) clearance for the BIO BOOST. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Bio Compression Systems, Inc. (Broadview Heights, US). The FDA issued a Cleared decision on October 28, 1996, 199 days after receiving the submission on April 12, 1996.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K961426 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1996 |
| Decision Date | October 28, 1996 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |