The following data is part of a premarket notification filed by Counter Scientific Development (gz) Ltd. with the FDA for Counter Otc Tens Device.
| Device ID | K132993 |
| 510k Number | K132993 |
| Device Name: | COUNTER OTC TENS DEVICE |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD. 11820 RED HIBISCUS DRIVE Bonita Springs, FL 34135 |
| Contact | Guenter Ginsberg |
| Correspondent | Guenter Ginsberg COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD. 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 | 2013-09-24 |
| Decision Date | 2014-04-24 |
| Summary: | summary |