The following data is part of a premarket notification filed by Pain Relief Technologies with the FDA for Electropulse.
Device ID | K051128 |
510k Number | K051128 |
Device Name: | ELECTROPULSE |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | PAIN RELIEF TECHNOLOGIES 15440 N. 71ST STREET #215 Scottsdale, AZ 85254 |
Contact | Kendall Gorham |
Correspondent | Kendall Gorham PAIN RELIEF TECHNOLOGIES 15440 N. 71ST STREET #215 Scottsdale, AZ 85254 |
Product Code | GZJ |
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 | 2005-05-03 |
Decision Date | 2006-03-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ELECTROPULSE 73472930 1357725 Dead/Cancelled |
BESTOBELL U.K. LIMITED 1984-03-29 |
ELECTROPULSE 72450837 1022933 Dead/Expired |
ENERGY SCIENCES INC. 1973-03-08 |