The following data is part of a premarket notification filed by Cathay Manufacturing Corp. with the FDA for Tens Electrodes.
Device ID | K160081 |
510k Number | K160081 |
Device Name: | TENS Electrodes |
Classification | Electrode, Cutaneous |
Applicant | CATHAY MANUFACTURING CORP. No. 328, Xishe Road, Maogang Town, Songjiang Area Shanghai, CN 201607 |
Contact | Ren Ren |
Correspondent | Fan Tao Shanghai YunTao Management Consultant Room 202, No. 14, Lane 986, Gaosi Road Pudong District Shanghai, CN 201203 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-01-15 |
Decision Date | 2016-10-19 |
Summary: | summary |