The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Multistim Plus.
Device ID | K895983 |
510k Number | K895983 |
Device Name: | MULTISTIM PLUS |
Classification | Stimulator, Muscle, Powered |
Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
Contact | Gagne |
Correspondent | Gagne EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-25 |
Decision Date | 1990-02-20 |