The following data is part of a premarket notification filed by Shenzhen Bestpad Technology Development Co., Ltd with the FDA for Electrodes Pad.
Device ID | K190700 |
510k Number | K190700 |
Device Name: | ELECTRODES PAD |
Classification | Electrode, Cutaneous |
Applicant | Shenzhen Bestpad Technology Development Co., Ltd A16A17 Dong Jing Run Factory A301, Fourth Industrial Zone Shenzhen, CN 518105 |
Contact | Junwei Xu |
Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center ,Guimiao Road Shenzhen, CN 518000 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-18 |
Decision Date | 2019-06-14 |