The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Mobilimb Hand Exerciser.
| Device ID | K870402 |
| 510k Number | K870402 |
| Device Name: | MOBILIMB HAND EXERCISER |
| Classification | Exerciser, Powered |
| Applicant | BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Contact | Kevin J Dunleavy |
| Correspondent | Kevin J Dunleavy BIODYNAMIC TECHNOLOGIES, INC. 727 TWENTY-THIRD ST. SOUTH Arlington, VA 22202 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-02 |
| Decision Date | 1987-03-16 |