The following data is part of a premarket notification filed by Toronto Medical, Inc. with the FDA for Revolution Lower Limb Cpm Unit.
| Device ID | K935808 |
| 510k Number | K935808 |
| Device Name: | REVOLUTION LOWER LIMB CPM UNIT |
| Classification | Exerciser, Powered |
| Applicant | TORONTO MEDICAL, INC. 901 DILLINGHAM RD. PICKERING, ONTARIO Canada L1w2y5, CA |
| Contact | Barbara Holt |
| Correspondent | Barbara Holt TORONTO MEDICAL, INC. 901 DILLINGHAM RD. PICKERING, ONTARIO Canada L1w2y5, CA |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-02 |
| Decision Date | 1994-03-18 |