The following data is part of a premarket notification filed by Techlink International with the FDA for Neurodyn Portable Tens Nfes, Neurodyn Portable Tens.
| Device ID | K131923 |
| 510k Number | K131923 |
| Device Name: | NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | TECHLINK INTERNATIONAL PO BOX 694125 Miami, FL 33269 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad TECHLINK INTERNATIONAL PO BOX 694125 Miami, FL 33269 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-26 |
| Decision Date | 2014-07-03 |
| Summary: | summary |