The following data is part of a premarket notification filed by Nisha Communication Industries with the FDA for Electronic Muscle Stimulator - Microstim J-1304d.
Device ID | K980040 |
510k Number | K980040 |
Device Name: | ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D |
Classification | Stimulator, Muscle, Powered |
Applicant | NISHA COMMUNICATION INDUSTRIES 10201,LINDLEY AVE. APT. J 126 Northbridge, CA 91325 |
Contact | Nisha Johari |
Correspondent | Nisha Johari NISHA COMMUNICATION INDUSTRIES 10201,LINDLEY AVE. APT. J 126 Northbridge, CA 91325 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-05 |
Decision Date | 1998-07-13 |
Summary: | summary |