The following data is part of a premarket notification filed by Mwr Electronics Industrial Co. with the FDA for Buzbee.
| Device ID | K982173 |
| 510k Number | K982173 |
| Device Name: | BUZBEE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MWR ELECTRONICS INDUSTRIAL CO. 21 ROSE RD. Goodwood, Capetown, ZA |
| Contact | Manfred W Roscher |
| Correspondent | Manfred W Roscher MWR ELECTRONICS INDUSTRIAL CO. 21 ROSE RD. Goodwood, Capetown, ZA |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-19 |
| Decision Date | 1999-03-11 |