The following data is part of a premarket notification filed by Pain Relief Technologies with the FDA for Electropulse-cosmetic.
Device ID | K113724 |
510k Number | K113724 |
Device Name: | ELECTROPULSE-COSMETIC |
Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
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 | NFO |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-19 |
Decision Date | 2012-02-15 |