The following data is part of a premarket notification filed by Breg, Inc. with the FDA for Flexmate K500.
| Device ID | K950755 |
| 510k Number | K950755 |
| Device Name: | FLEXMATE K500 |
| Classification | Exerciser, Powered |
| Applicant | BREG, INC. 1261 LIBERTY WAY Vista, CA 92083 |
| Contact | Barber |
| Correspondent | Barber BREG, INC. 1261 LIBERTY WAY Vista, CA 92083 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-17 |
| Decision Date | 1995-10-05 |