The following data is part of a premarket notification filed by Theratech, Inc. with the FDA for Ttech Model 200e + Tens Device.
| Device ID | K021436 |
| 510k Number | K021436 |
| Device Name: | TTECH MODEL 200E + TENS DEVICE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | THERATECH, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk THERATECH, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-06 |
| Decision Date | 2002-07-30 |
| Summary: | summary |