The following data is part of a premarket notification filed by Heat In A Click Llc with the FDA for Palm Tens.
| Device ID | K150308 |
| 510k Number | K150308 |
| Device Name: | Palm TENS |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | HEAT IN A CLICK LLC 1924 TIGERTAIL BLVD Dania, FL 33304 |
| Contact | Guy Levi |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-10-20 |