K922603 is an FDA 510(k) clearance for the TOTAL WORK INTEGRATOR, MODEL #940-110. This device is classified as a Exerciser, Measuring (Class II - Special Controls, product code ISD).
Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on June 19, 1992, 17 days after receiving the submission on June 2, 1992.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K922603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1992 |
| Decision Date | June 19, 1992 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ISD — Exerciser, Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |