The following data is part of a premarket notification filed by Frye Electronics, Inc. with the FDA for Type 4000 Transcutaneous Elec. Stim..
| Device ID | K800630 |
| 510k Number | K800630 |
| Device Name: | TYPE 4000 TRANSCUTANEOUS ELEC. STIM. |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | FRYE ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-20 |
| Decision Date | 1980-04-02 |