The following data is part of a premarket notification filed by Shenzhen Roundwhale Technology Co., Ltd. with the FDA for R-c1 Tens And Ems Stimulator; R-e1- Ems Stimulator; R-t1 Tens Stimulator.
| Device ID | K181688 |
| 510k Number | K181688 |
| Device Name: | R-C1 TENS And EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Shenzhen Roundwhale Technology Co., Ltd. No. 615, Building C Of Sanlian Industrial Zone, Shiyan Baoan District Shenzhen, CN 518108 |
| Contact | Kevin Zhang |
| Correspondent | Kevin Zhang Shenzhen Roundwhale Technology Co., Ltd. No. 615, Building C Of Sanlian Industrial Zone, Shiyan Baoan District Shenzhen, CN 518108 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-26 |
| Decision Date | 2018-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815991023037 | K181688 | 000 |
| 20815991023020 | K181688 | 000 |
| 20815991023013 | K181688 | 000 |