The following data is part of a premarket notification filed by Verimed Holdings, Inc. with the FDA for Phyaction 787.
Device ID | K930670 |
510k Number | K930670 |
Device Name: | PHYACTION 787 |
Classification | Stimulator, Muscle, Powered |
Applicant | VERIMED HOLDINGS, INC. 1401 E. BROWARD BLVD. SUITE 200 Fort Lauderdale, FL 33301 |
Contact | Christopher Chase |
Correspondent | Christopher Chase VERIMED HOLDINGS, INC. 1401 E. BROWARD BLVD. SUITE 200 Fort Lauderdale, FL 33301 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-09 |
Decision Date | 1993-07-02 |