Electrical Muscle Stimulator--Pgs 2000 Tens Device
by Universal Technology Systems, Inc. 510(k)
Active
510(k) K895760
Overview
The Electrical Muscle Stimulator - PGS 2000 TENS Device is a surface electrical muscle stimulator designed to deliver low-frequency electrical pulses through skin electrodes to elicit muscle contractions or modulate pain signals. It operates in TENS mode for pain management and is classified under product code IPF. The device is intended for use in physical medicine settings as an adjunctive therapy.
The device is supplied by Universal Technology Systems, Inc. and was authorized through FDA 510(k) clearance under K895760, with a determination of substantial equivalence. It is a traditional clearance device reviewed by the Physical Medicine advisory committee. The device is single-use or reusable depending on electrode application, and no MRI safety claims are specified in the available data. Storage conditions and specific size variants are not detailed in the regulatory record.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895760 | Date2 Jan 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Universal Technology Systems, Inc.
Questions
What is the PGS 2000 TENS Device used for?
The PGS 2000 TENS Device is a surface electrical muscle stimulator designed to deliver low-frequency electrical pulses through skin electrodes. It is used in physical medicine settings as an adjunctive therapy for pain management and to elicit muscle contractions.
How is the device supplied and what is its regulatory status?
The device is supplied by Universal Technology Systems, Inc. It was authorized through FDA 510(k) clearance under K895760 with a determination of substantial equivalence. It is classified under product code IPF and reviewed by the Physical Medicine advisory committee.
Is the PGS 2000 TENS Device single-use or reusable?
The device's reusability depends on the electrode application. While the device itself may be reusable, the electrodes may be designed for single or multiple uses, though specific details on electrode longevity are not provided in the regulatory record.
What are the storage conditions and size variants for this device?
Specific storage conditions and size variants for the PGS 2000 TENS Device are not detailed in the available regulatory data. Users should refer to the manufacturer's instructions for proper storage and handling.
Does the PGS 2000 TENS Device have MRI safety specifications?
No MRI safety claims are specified for the PGS 2000 TENS Device in the available regulatory data. It should not be used in an MRI environment unless explicitly cleared by the manufacturer.