The following data is part of a premarket notification filed by Bioflex, Inc. with the FDA for Bioflex Garments, Assorted Models.
| Device ID | K944543 |
| 510k Number | K944543 |
| Device Name: | BIOFLEX GARMENTS, ASSORTED MODELS |
| Classification | Electrode, Cutaneous |
| Applicant | BIOFLEX, INC. 736 KENWICK RD. Columbus, OH 43209 |
| Contact | Philip Muccio |
| Correspondent | Philip Muccio BIOFLEX, INC. 736 KENWICK RD. Columbus, OH 43209 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-15 |
| Decision Date | 1995-07-19 |