The following data is part of a premarket notification filed by Pain Relief Technologies with the FDA for Electropulse - Low Back Pain.
Device ID | K062532 |
510k Number | K062532 |
Device Name: | ELECTROPULSE - LOW BACK PAIN |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | PAIN RELIEF TECHNOLOGIES 15048 SW CAPSTONE CT. Beaverton, OR 97007 |
Contact | Kendall Gorham |
Correspondent | Kendall Gorham PAIN RELIEF TECHNOLOGIES 15048 SW CAPSTONE CT. Beaverton, OR 97007 |
Product Code | NUH |
Subsequent Product Code | ILY |
Subsequent Product Code | IRO |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-28 |
Decision Date | 2007-02-09 |