The following data is part of a premarket notification filed by Counter Scientific Development (gz) Ltd with the FDA for Counter Otc Tens Device, Model Csd-737z.
| Device ID | K151279 |
| 510k Number | K151279 |
| Device Name: | Counter OTC TENS Device, Model CSD-737Z |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD 2ND &3RD FLOOR, BLD. 6, DAPIAN INDUSTRIAL ZONE, TANGXIA RD., TIANHE DISTRICT Guangzhou, CN 510665 |
| Contact | Jiang Eagle |
| Correspondent | Guenter Ginsberg Media Trade Corporation 11820 RED HIBISCUS DRIVE Bonita Springs, FL 34135 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-14 |
| Decision Date | 2015-12-16 |