The following data is part of a premarket notification filed by General Physiotherapy, Inc. with the FDA for Sanyo Electronic Muscle Stimulators.
Device ID | K850047 |
510k Number | K850047 |
Device Name: | SANYO ELECTRONIC MUSCLE STIMULATORS |
Classification | Stimulator, Muscle, Powered |
Applicant | GENERAL PHYSIOTHERAPY, INC. 1520 WASHINGTON AVE. St. Louis, MO 63103 |
Contact | Joseph J Leydon |
Correspondent | Joseph J Leydon GENERAL PHYSIOTHERAPY, INC. 1520 WASHINGTON AVE. St. Louis, MO 63103 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-08 |
Decision Date | 1985-03-05 |