The following data is part of a premarket notification filed by Toronto Medical Corp. with the FDA for Multilink Shoulder Cpm Unit.
| Device ID | K935587 |
| 510k Number | K935587 |
| Device Name: | MULTILINK SHOULDER CPM UNIT |
| Classification | Exerciser, Powered |
| Applicant | TORONTO MEDICAL CORP. 901 DILLINGHAM ROAD PICKERING, ONTARIO Canada L1w 2y5, CA |
| Contact | Barbara L Holt |
| Correspondent | Barbara L Holt 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 | 1993-11-16 |
| Decision Date | 1994-12-14 |