The following data is part of a premarket notification filed by Universal Technology Systems, Inc. with the FDA for Electrical Muscle Stimulator Device ( Pgs-4000).
Device ID | K980346 |
510k Number | K980346 |
Device Name: | ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000) |
Classification | Stimulator, Muscle, Powered |
Applicant | UNIVERSAL TECHNOLOGY SYSTEMS, INC. 5150-4 TIMUQUANA RD. Jacksonville, FL 32210 |
Contact | Gary Heiney |
Correspondent | Gary Heiney UNIVERSAL TECHNOLOGY SYSTEMS, INC. 5150-4 TIMUQUANA RD. Jacksonville, FL 32210 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-28 |
Decision Date | 1998-04-28 |