The following data is part of a premarket notification filed by Progressive Electrical Therapeutics with the FDA for The Signature Series, Ic Ii.
Device ID | K933196 |
510k Number | K933196 |
Device Name: | THE SIGNATURE SERIES, IC II |
Classification | Stimulator, Muscle, Powered |
Applicant | PROGRESSIVE ELECTRICAL THERAPEUTICS 122 W. WALNUT Nevada, MO 64772 |
Contact | Gary Huddleston |
Correspondent | Gary Huddleston PROGRESSIVE ELECTRICAL THERAPEUTICS 122 W. WALNUT 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 | 1993-07-01 |
Decision Date | 1994-07-12 |