Submission Details
| 510(k) Number | K925839 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 1992 |
| Decision Date | June 24, 1993 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
K925839 is an FDA 510(k) clearance for the TRACKMASTER. This device is classified as a Treadmill, Powered (Class I — General Controls, product code IOL).
Submitted by Jas Manufacturing Co., Inc. (Carrollton, US). The FDA issued a Cleared decision on June 24, 1993, 218 days after receiving the submission on November 18, 1992.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.
| 510(k) Number | K925839 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 1992 |
| Decision Date | June 24, 1993 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IOL — Treadmill, Powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5380 |