← Back to catalogue

Omnistim 500 Pro

FDA UDI

Class II (US FDA UDI)

by Accelerated Care Plus Corp.

Identity

Trade Name
Omnistim 500 Pro FDA UDI
Generic Name
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Device Name
The Omnistim® 500 Pro is designed to provide Interferential Current Therapy (IFC), Medium Frequency Alternating Currents (MFAC), Low Voltage Pulsed Current (LVPC) and High Voltage Pulsed Current Therapy (HVPC). Its two separate generators produce medium frequency (2000, 2500, 4000 or 5000 Hz) alternating current in continuous or modulated modes. Two isolated output circuits with independent intensity controls are provided. The Omnistim® 500 Pro MFAC and LVPC modes with fully adjustable ON and OFF times and ON and OFF ramps provides a wide variety of uses for muscle re-education and muscle spasm reduction protocols for innervated muscle. The Omnistim® 500 Pro provides High Voltage Pulsed Current (HVPC) on one channel. Continuous or surged operation with fully adjustable ON and OFF times and ramps allow applications of HVPC therapy. Increasing circulation, pain control and muscle re-ed can be set up in this mode. FDA UDI
Model / Reference
100500C FDA UDI
Description
The Omnistim® 500 Pro is designed to provide Interferential Current Therapy (IFC), Medium Frequency Alternating Currents (MFAC), Low Voltage Pulsed Current (LVPC) and High Voltage Pulsed Current Therapy (HVPC). Its two separate generators produce medium frequency (2000, 2500, 4000 or 5000 Hz) alternating current in continuous or modulated modes. Two isolated output circuits with independent intensity controls are provided. The Omnistim® 500 Pro MFAC and LVPC modes with fully adjustable ON and OFF times and ON and OFF ramps provides a wide variety of uses for muscle re-education and muscle spasm reduction protocols for innervated muscle. The Omnistim® 500 Pro provides High Voltage Pulsed Current (HVPC) on one channel. Continuous or surged operation with fully adjustable ON and OFF times and ramps allow applications of HVPC therapy. Increasing circulation, pain control and muscle re-ed can be set up in this mode. FDA UDI

Identifiers

Primary DI / UDI-DI
00858703006016 FDA UDI
510(k) Number
K874076 FDA UDI
FDA Product Code
IPF FDA UDI
GMDN Term
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Physical therapy transcutaneous electrical stimulation system, line-powered

Omnistim 500 Pro by Accelerated Care Plus Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physical therapy transcutaneous electrical stimulation system, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Accelerated Care Plus Corp.

Sources (1)

  • FDA UDI 7b9178b5-0a1a-4536-84c2-434333ff7447 35 fields · synced May 31, 2026