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 |