The following data is part of a premarket notification filed by Toronto Medical Corp. with the FDA for Mobilimb T1 Toe Cpm Unit.
| Device ID | K925926 |
| 510k Number | K925926 |
| Device Name: | MOBILIMB T1 TOE CPM UNIT |
| Classification | Exerciser, Powered |
| Applicant | TORONTO MEDICAL CORP. 901 DILLINGHAM ROAD PICKERING, ONTARIO Canada L1w 2y5, CA |
| Contact | Paula Donnelly |
| Correspondent | Paula Donnelly TORONTO MEDICAL CORP. 901 DILLINGHAM ROAD PICKERING, ONTARIO Canada L1w 2y5, CA |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-23 |
| Decision Date | 1993-03-22 |