The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Universal Power Flex.
| Device ID | K851177 |
| 510k Number | K851177 |
| Device Name: | UNIVERSAL POWER FLEX |
| Classification | Exerciser, Powered |
| Applicant | BIODYNAMIC TECHNOLOGIES, INC. LARSON & TAYLOR 727 TWENTY-THIRD ST. S. Arlington, VA 22208 |
| Contact | Brewster B Taylor |
| Correspondent | Brewster B Taylor BIODYNAMIC TECHNOLOGIES, INC. LARSON & TAYLOR 727 TWENTY-THIRD ST. S. Arlington, VA 22208 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-25 |
| Decision Date | 1985-06-28 |