The following data is part of a premarket notification filed by Electro Therapeutic Devices, Inc. with the FDA for Transcutaneous Elect. Nerve Stimul-myostim 410.
| Device ID | K853719 |
| 510k Number | K853719 |
| Device Name: | TRANSCUTANEOUS ELECT. NERVE STIMUL-MYOSTIM 410 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | ELECTRO THERAPEUTIC DEVICES, INC. 570 HOOD RD., STE. 14 Markham, Ontario, CA L3r 4g7 |
| Contact | Choong |
| Correspondent | Choong ELECTRO THERAPEUTIC DEVICES, INC. 570 HOOD RD., STE. 14 Markham, Ontario, CA L3r 4g7 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-05 |
| Decision Date | 1985-12-04 |