The following data is part of a premarket notification filed by Toronto Medical Corp. with the FDA for Mobilimb Hand C.p.m. Unit.
| Device ID | K880336 |
| 510k Number | K880336 |
| Device Name: | MOBILIMB HAND C.P.M. UNIT |
| Classification | Exerciser, Finger, Powered |
| Applicant | TORONTO MEDICAL CORP. 800 LIVERMORE ST. SUITE 117 Yellow Springs, OH 45387 |
| Contact | Douglas Davidson |
| Correspondent | Douglas Davidson TORONTO MEDICAL CORP. 800 LIVERMORE ST. SUITE 117 Yellow Springs, OH 45387 |
| Product Code | JFA |
| CFR Regulation Number | 890.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-02-16 |