The following data is part of a premarket notification filed by Prevent Products, Inc. with the FDA for Ankle Calf Exerciser.
| Device ID | K942618 |
| 510k Number | K942618 |
| Device Name: | ANKLE CALF EXERCISER |
| Classification | Exerciser, Powered |
| Applicant | PREVENT PRODUCTS, INC. 1167 OTTAWA AVE. W St Paul, MN 55118 |
| Contact | Carol Garcia |
| Correspondent | Carol Garcia PREVENT PRODUCTS, INC. 1167 OTTAWA AVE. W St Paul, MN 55118 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-19 |
| Decision Date | 1994-06-22 |