The following data is part of a premarket notification filed by Empi with the FDA for Empi Active Transcutaneous Nerve Stimulator.
| Device ID | K090922 |
| 510k Number | K090922 |
| Device Name: | EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMPI CLEAR LAKE INDUSTRIAL PARK Clear Lake, SD 57226 |
| Contact | Sandra Walrod |
| Correspondent | Sandra Walrod EMPI CLEAR LAKE INDUSTRIAL PARK Clear Lake, SD 57226 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-06-05 |
| Summary: | summary |