The following data is part of a premarket notification filed by Te Me Na S.a.r.l. with the FDA for Te Me Na Polystim Nerve Stimilator.
| Device ID | K990323 |
| 510k Number | K990323 |
| Device Name: | TE ME NA POLYSTIM NERVE STIMILATOR |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | TE ME NA S.A.R.L. 390 SCARLET BLVD. Oldsmar, FL 34677 |
| Contact | Joe Harms |
| Correspondent | Joe Harms TE ME NA S.A.R.L. 390 SCARLET BLVD. Oldsmar, FL 34677 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-02 |
| Decision Date | 2001-09-28 |