Submission Details
| 510(k) Number | K911751 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 1991 |
| Decision Date | May 29, 1991 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
K911751 is an FDA 510(k) clearance for the MEDTRACK TREADMILL, a Treadmill, Powered (Class I — General Controls, product code IOL), submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on May 29, 1991, 41 days after receiving the submission on April 18, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.
| 510(k) Number | K911751 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 1991 |
| Decision Date | May 29, 1991 |
| Days to Decision | 41 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 |