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Winback

FDA UDI

Class II (US FDA UDI)

by Winback Go East

Identity

Trade Name
WINBACK FDA UDI
Generic Name
Multi-modality physical therapy system, professional-use FDA UDI
Device Name
The Hi-TENS device generates a high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld and active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a resistive monopolar mode. The product consists of a power console, LCD monitor, and accessories including resistive electrodes. The unit can provide one level of treatment frequency at 300kHz. Electrodes are attached with an active cable that plugs in on the lateral side of the unit. A safety switch feature allows the patient to shut down the unit in the event of any discomfort. FDA UDI
Model / Reference
Hi-TENS FDA UDI
Description
The Hi-TENS device generates a high frequency sinusoidal current with a monopolar mode of application using two electrodes. A neutral electrode is placed in contact with the patient and a handheld and active electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed and RF therapy can be provided. The device can be operated in a resistive monopolar mode. The product consists of a power console, LCD monitor, and accessories including resistive electrodes. The unit can provide one level of treatment frequency at 300kHz. Electrodes are attached with an active cable that plugs in on the lateral side of the unit. A safety switch feature allows the patient to shut down the unit in the event of any discomfort. FDA UDI

Identifiers

Primary DI / UDI-DI
08800099100146 FDA UDI
510(k) Number
K220014 FDA UDI
FDA Product Code
PBX FDA UDI
GMDN Term
Multi-modality physical therapy system, professional-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

No

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: Multi-modality physical therapy system, professional-use

Winback by Winback Go East — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality physical therapy system, professional-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Winback Go East

Sources (1)

  • FDA UDI 8e4b5d25-a13e-4b09-8fe1-941a88c88235 34 fields · synced May 29, 2026