The following data is part of a premarket notification filed by Bio-research Associates, Inc. with the FDA for Bio-tens.
| Device ID | K844618 |
| 510k Number | K844618 |
| Device Name: | BIO-TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BIO-RESEARCH ASSOCIATES, INC. 2315 NORTH LAKE DR. Milwaukee, WI 53211 |
| Contact | John C Radke |
| Correspondent | John C Radke BIO-RESEARCH ASSOCIATES, INC. 2315 NORTH LAKE DR. Milwaukee, WI 53211 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-27 |
| Decision Date | 1985-08-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIO-TENS 73536443 1366546 Dead/Cancelled |
BIO-RESEARCH ASSOCIATES, INC. 1985-05-08 |