The following data is part of a premarket notification filed by Universal Technology Systems, Inc. with the FDA for Electrical Muscle Stimulator--pgs 2000 Tens Device.
| Device ID | K895760 |
| 510k Number | K895760 |
| Device Name: | ELECTRICAL MUSCLE STIMULATOR--PGS 2000 TENS DEVICE |
| Classification | Stimulator, Muscle, Powered |
| Applicant | UNIVERSAL TECHNOLOGY SYSTEMS, INC. P.O. BOX 7908 Jacksonville, FL 32238 |
| Contact | Thomas J Mcenany |
| Correspondent | Thomas J Mcenany UNIVERSAL TECHNOLOGY SYSTEMS, INC. P.O. BOX 7908 Jacksonville, FL 32238 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1990-01-02 |