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 |