The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Electrical Neuro-muscular Stimulator.
Device ID | K840895 |
510k Number | K840895 |
Device Name: | ELECTRICAL NEURO-MUSCULAR STIMULATOR |
Classification | Stimulator, Muscle, Powered |
Applicant | RICHARDS MEDICAL CO., 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 | 1984-02-27 |
Decision Date | 1984-04-24 |