Unifit

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref K-UNIFIT

by TensCare Ltd

Identity

Trade Name: Unifit EUDAMED
TensCare FDA UDI
Generic Name: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name: Unifit EUDAMED
Unifit combines the treatment capabilities of a TENS device, an EMS or NMES device, and a relaxing massage stimulator in one unit. It sends a small and gentle stimulation (similar to your natural nerve impulses) to the muscles being treated via two or four auto-adhesive electrode pads, in order to help you to firm and tone your body. Unifit is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Unifit is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has preset treatment programs and manually adjustable programmes are available. FDA UDI
Model / Reference: K-UNIFIT EUDAMED
Unifit FDA UDI
Description: Unifit combines the treatment capabilities of a TENS device, an EMS or NMES device, and a relaxing massage stimulator in one unit. It sends a small and gentle stimulation (similar to your natural nerve impulses) to the muscles being treated via two or four auto-adhesive electrode pads, in order to help you to firm and tone your body. Unifit is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Unifit is intended for over-the-counter use. The device is battery powered, two channels home use neuromuscular stimulation. The device is supplied with self-adhesive electrodes which connect to the control unit by cable and plug and are placed on patients’ intact skin by the end user. Electrical stimulation is delivered via self-adhesive electrodes to nerves and muscles. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls. The unit is intended for home use by the patient, and is designed with simplicity and ease of use in mind. It has preset treatment programs and manually adjustable programmes are available. FDA UDI

Identifiers

Catalog Number: K-UNIFIT FDA UDI
Primary DI / UDI-DI: 05033435136209 EUDAMEDFDA UDI
Basic UDI-DI: 5033435K0017627 EUDAMED
510(k) Number: K200694 FDA UDI
FDA Product Code: NUH FDA UDI
NGX FDA UDI
EMDN Code: Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES EUDAMED
GMDN Term: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 882.5890 FDA UDI
890.5850 FDA UDI
Medical Purpose: to be used in the home healthcare environment to improve muscle tone and bulk, as well as provide symptomatic relief and management of acute or chronic localised pain and muscle pain. It is suitable for use by all who can control the device and understand the instructions. EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Unifit by TensCare Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	5033435K0017627	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: TensCare Ltd
EUDAMED SRN: UK-PR-000039358

Sources (2)

EUDAMED b889932a-9a44-4571-8374-b6de8bd12b5f 61 fields · synced Jun 19, 2026
FDA UDI 252d985b-f93a-4cb9-ad3e-6e50dd32a0bc 35 fields · synced May 29, 2026