The following data is part of a premarket notification filed by Toronto Medical Corp. with the FDA for Mobilimb Cpm Shoulder Unit.
| Device ID | K891345 |
| 510k Number | K891345 |
| Device Name: | MOBILIMB CPM SHOULDER UNIT |
| Classification | Exerciser, Powered |
| Applicant | TORONTO MEDICAL CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan TORONTO MEDICAL CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET N.W. Washington, DC 20004 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-09 |
| Decision Date | 1989-04-24 |