The following data is part of a premarket notification filed by Counter Scientific Development (gz) Ltd with the FDA for Otc Tens Device, Model Pts-iv.
| Device ID | K161537 |
| 510k Number | K161537 |
| Device Name: | OTC TENS Device, Model PTS-IV |
| 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 | Wendy Poon |
| 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 | 2016-06-03 |
| Decision Date | 2016-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970368250017 | K161537 | 000 |