The following data is part of a premarket notification filed by Prospera Corporation with the FDA for Electronic Pulse Massager Tens Electronic Pulse Massager.
| Device ID | K113544 |
| 510k Number | K113544 |
| Device Name: | ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | PROSPERA CORPORATION 405 BOULDER CT SUITE 500 Pleasanton, CA 94566 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls PROSPERA CORPORATION 405 BOULDER CT SUITE 500 Pleasanton, CA 94566 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-01 |
| Decision Date | 2012-07-27 |
| Summary: | summary |