The following data is part of a premarket notification filed by Prospera Corporation with the FDA for Prospera Otc Tens Electronic Pulse Massager.
| Device ID | K122744 |
| 510k Number | K122744 |
| Device Name: | PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | PROSPERA CORPORATION 5776 STONERIDGE MALL RD SUITE 288 Pleasanton, CA 94588 |
| Contact | Leon E Jew |
| Correspondent | Leon E Jew PROSPERA CORPORATION 5776 STONERIDGE MALL RD SUITE 288 Pleasanton, CA 94588 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-07 |
| Decision Date | 2013-03-28 |
| Summary: | summary |