The following data is part of a premarket notification filed by Emsi with the FDA for Tens/if 14.
| Device ID | K071869 |
| 510k Number | K071869 |
| Device Name: | TENS/IF 14 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EMSI 901 KING STREET SUITE 200 Alexandria, VA 22331 |
| Contact | Cherita James |
| Correspondent | Cherita James EMSI 901 KING STREET SUITE 200 Alexandria, VA 22331 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-06 |
| Decision Date | 2008-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858688006957 | K071869 | 000 |
| 00858688006940 | K071869 | 000 |
| 00858688006087 | K071869 | 000 |
| 00858688006070 | K071869 | 000 |
| 00858688006001 | K071869 | 000 |