K781889 is an FDA 510(k) clearance for the COLLINS PEDALMATE 2. This device is classified as a Exerciser, Measuring (Class II - Special Controls, product code ISD).
Submitted by Warren E. Collins, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1978, 15 days after receiving the submission on November 7, 1978.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5360.
| 510(k) Number | K781889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1978 |
| Decision Date | November 22, 1978 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ISD — Exerciser, Measuring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5360 |