The following data is part of a premarket notification filed by Shenzhen Roundwhale Technology Co., Ltd. with the FDA for Electrical Stimulator - Model R-c1 Tens And Ems Stimulator, Model R-e1 Ems Stimulator, Model R-t1 Tens Stimulator.
| Device ID | K180956 |
| 510k Number | K180956 |
| Device Name: | Electrical Stimulator - Model R-C1 TENS And EMS Stimulator, Model R-E1 EMS Stimulator, Model R-T1 TENS Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| 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 | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-12 |
| Decision Date | 2018-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840001700086 | K180956 | 000 |
| 10840001700021 | K180956 | 000 |
| 10840001700038 | K180956 | 000 |
| 00840001700048 | K180956 | 000 |
| 00840001700055 | K180956 | 000 |
| 00840001700062 | K180956 | 000 |
| 00840001700079 | K180956 | 000 |
| 18400017010013 | K180956 | 000 |
| 00857771003996 | K180956 | 000 |
| 10840001700014 | K180956 | 000 |