The following data is part of a premarket notification filed by Progressive Electrical Therapeutics with the FDA for The Signature Series, Magnum 100.
Device ID | K934919 |
510k Number | K934919 |
Device Name: | THE SIGNATURE SERIES, MAGNUM 100 |
Classification | Stimulator, Muscle, Powered |
Applicant | PROGRESSIVE ELECTRICAL THERAPEUTICS 200 S. ALMA Nevada, MO 64772 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-14 |
Decision Date | 1994-04-06 |