The following data is part of a premarket notification filed by Shenzhen Roundwhale Technology Co., Ltd. with the FDA for Combo Electrotherapy Device.
| Device ID | K192087 |
| 510k Number | K192087 |
| Device Name: | Combo Electrotherapy Device |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen Roundwhale Technology Co., Ltd. 202, 2/F, Building 27, Dafa Industrial Park Longxi Community, Longgang Street Shenzhen, CN 518108 |
| Contact | Kevin Zhang |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 2012#, Gebu Commercial Building, Hongxing Community, Songgang Street Shenzhen, CN 518105 |
| Product Code | NUH |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | NGX |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2019-11-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840001700123 | K192087 | 000 |
| 00815290017283 | K192087 | 000 |
| 00815290017306 | K192087 | 000 |
| 10815290017266 | K192087 | 000 |