The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for Collins Pedalmate 2.
| Device ID | K781889 |
| 510k Number | K781889 |
| Device Name: | COLLINS PEDALMATE 2 |
| Classification | Exerciser, Measuring |
| Applicant | WARREN E. COLLINS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ISD |
| CFR Regulation Number | 890.5360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-07 |
| Decision Date | 1978-11-22 |