The following data is part of a premarket notification filed by Newlife Sciences, Llc with the FDA for Newlife Sciences Llc, Model Tmr.
| Device ID | K070474 |
| 510k Number | K070474 |
| Device Name: | NEWLIFE SCIENCES LLC, MODEL TMR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | NEWLIFE SCIENCES, LLC 51 PONDVIEW DR. Merrimack, NH 03054 -4162 |
| Contact | Ronald Weinstock |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-02-20 |
| Decision Date | 2007-04-25 |
| Summary: | summary |