The following data is part of a premarket notification filed by Ergomedics, Inc. with the FDA for Backcycler Cpm(tm).
| Device ID | K945690 |
| 510k Number | K945690 |
| Device Name: | BACKCYCLER CPM(TM) |
| Classification | Exerciser, Powered |
| Applicant | ERGOMEDICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | William A Morton |
| Correspondent | William A Morton ERGOMEDICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-21 |
| Decision Date | 1995-06-22 |