The following data is part of a premarket notification filed by Counter Scientific Development (gz) Ltd with the FDA for Pain Therapy System, Model Pts-ii.
| Device ID | K150277 |
| 510k Number | K150277 |
| Device Name: | Pain Therapy System, Model PTS-II |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD 2ND &3RD FLOOR, BLD. 6, DAPIAN INDUSTRIAL ZONE, TANGZIA RD., TIANHE DISTRICT Guangzhou, CN 510665 |
| Contact | Eagle Eagle |
| Correspondent | Guenter Ginsberg MEDIA TRADE CORPORATION 11820 RED HIBISCUS DRIVE Bonita Springs, FL 34135 |
| Product Code | NUH |
| Subsequent Product Code | GZJ |
| 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 | 2015-02-05 |
| Decision Date | 2016-02-12 |
| Summary: | summary |