The following data is part of a premarket notification filed by Universal Technology Systems, Inc. with the FDA for Uts Electrical Muscle Stimulation Device-pgs 1500.
| Device ID | K905107 |
| 510k Number | K905107 |
| Device Name: | UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 |
| 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 | 1990-11-13 |
| Decision Date | 1991-08-19 |