K912057 is an FDA 510(k) clearance for the 4000 PT EXERCISE SYSTEM. This device is classified as a Exerciser, Measuring (Class II - Special Controls, product code ISD).
Submitted by Tri-Tech, Inc. (Fort Woth, US). The FDA issued a Cleared decision on October 24, 1991, 168 days after receiving the submission on May 9, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K912057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1991 |
| Decision Date | October 24, 1991 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | ISD — Exerciser, Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |