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 |