The following data is part of a premarket notification filed by Nemectron Medical, Inc. with the FDA for Electrodyn Cii-interferential Muscle.
Device ID | K810513 |
510k Number | K810513 |
Device Name: | ELECTRODYN CII-INTERFERENTIAL MUSCLE |
Classification | Stimulator, Muscle, Powered |
Applicant | NEMECTRON MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-24 |
Decision Date | 1981-05-11 |