The following data is part of a premarket notification filed by Gurin Products, Llc with the FDA for Electronic Pulse Massager.
| Device ID | K131933 |
| 510k Number | K131933 |
| Device Name: | ELECTRONIC PULSE MASSAGER |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | GURIN PRODUCTS, LLC 2522 CHAMBERS ROAD SUITE 100 Tustin, CA 92780 |
| Contact | Sanjay Gupta |
| Correspondent | Sanjay Gupta GURIN PRODUCTS, LLC 2522 CHAMBERS ROAD SUITE 100 Tustin, CA 92780 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2013-12-20 |
| Summary: | summary |