The following data is part of a premarket notification filed by Toronto Medical, Inc. with the FDA for A3 Ankle Cpm Unit.
| Device ID | K945121 |
| 510k Number | K945121 |
| Device Name: | A3 ANKLE CPM UNIT |
| Classification | Exerciser, Powered |
| Applicant | TORONTO MEDICAL, INC. 1390 SOUTH POTOMAC ST. SUITE 124 Aurora, CO 80012 |
| Contact | Barbara L Holt |
| Correspondent | Barbara L Holt TORONTO MEDICAL, INC. 1390 SOUTH POTOMAC ST. SUITE 124 Aurora, CO 80012 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-19 |
| Decision Date | 1995-02-17 |