The following data is part of a premarket notification filed by Empi with the FDA for Select Tens, Model 4600s.
| Device ID | K061650 |
| 510k Number | K061650 |
| Device Name: | SELECT TENS, MODEL 4600S |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
| Contact | Carl Beaurline |
| Correspondent | Carl Beaurline EMPI 599 CARDIGAN RD. St. Paul, MN 55126 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-13 |
| Decision Date | 2007-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912572439 | K061650 | 000 |