The following data is part of a premarket notification filed by Zmi Elecronics Ltd. with the FDA for Wireless Tens/ems, Bruno, Aela.
| Device ID | K220997 |
| 510k Number | K220997 |
| Device Name: | Wireless TENS/EMS, Bruno, Aela |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | ZMI Elecronics Ltd. 6F-1, 286-4, Shin Ya Road Kaohsiung, TW 806 |
| Contact | Lawerence Liu |
| Correspondent | Yuta Lee ZMI Elecronics Ltd. 6F-1, 286-4, Shin Ya Road Kaohsiung, TW 806 |
| Product Code | NUH |
| Subsequent Product Code | NGX |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-04 |
| Decision Date | 2022-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872332480 | K220997 | 000 |
| 04719872333395 | K220997 | 000 |
| 04719872333371 | K220997 | 000 |
| 04719872333357 | K220997 | 000 |
| 04719872333319 | K220997 | 000 |
| 04719872333302 | K220997 | 000 |
| 04719872333296 | K220997 | 000 |
| 04719872332107 | K220997 | 000 |
| 04719872332022 | K220997 | 000 |