The following data is part of a premarket notification filed by Electro Therapeutic Devices, Inc. with the FDA for Electrical Muscle Stimulator Model Myoaid.
Device ID | K875317 |
510k Number | K875317 |
Device Name: | ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID |
Classification | Stimulator, Muscle, Powered |
Applicant | ELECTRO THERAPEUTIC DEVICES, INC. 570 HOOD RD., STE. 14 Markham, Ontario, CA L3r 4g7 |
Contact | K. C Choong |
Correspondent | K. C Choong ELECTRO THERAPEUTIC DEVICES, INC. 570 HOOD RD., STE. 14 Markham, Ontario, CA L3r 4g7 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-29 |
Decision Date | 1989-09-08 |