The following data is part of a premarket notification filed by Shenzhen Kentro Medical Electronics Co., Ltd. with the FDA for Transcutaneous Electrical Nerve Stimulator, Model: Ktr-405.
Device ID | K220998 |
510k Number | K220998 |
Device Name: | Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | Shenzhen Kentro Medical Electronics Co., Ltd. 2nd Floor No 11,Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District Shenzhen, CN 518100 |
Contact | Zewu Zhang |
Correspondent | Yvonne Liu Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, CN 518052 |
Product Code | NUH |
Subsequent Product Code | GZJ |
Subsequent Product Code | IPF |
Subsequent Product Code | NGX |
Subsequent Product Code | NYN |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-04-04 |
Decision Date | 2022-08-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06924607702652 | K220998 | 000 |