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Perfect EMS

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref K-PEMS

by TensCare Ltd

Identity

Trade Name
Perfect EMS EUDAMED
TensCare FDA UDI
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name
Perfect EMS EUDAMED
Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS 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 six preset treatment programs and four manually adjustable programmes are available. FDA UDI
Model / Reference
K-PEMS EUDAMED
Perfect EMS FDA UDI
Description
Perfect EMS is a hand-held, home-use device designed to relief of pain and improve and facilitate muscle performance. Perfect EMS 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 six preset treatment programs and four manually adjustable programmes are available. FDA UDI

Identifiers

Catalog Number
K-PEMS FDA UDI
Primary DI / UDI-DI
05033435131419 EUDAMEDFDA UDI
Basic UDI-DI
5033435K00045ZL EUDAMED
510(k) Number
K200694 FDA UDI
FDA Product Code
NGX FDA UDI
NUH 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
890.5850 FDA UDI
882.5890 FDA UDI
Medical Purpose
Perfect EMS is a medical device designed 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

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Perfect EMS by TensCare Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
TensCare Ltd
EUDAMED SRN
UK-PR-000039358

Sources (3)

  • EUDAMED 1cdbef80-9a94-4ee1-a205-e3b4e1c92bf1 61 fields · synced Jul 17, 2026
  • FDA UDI fa5f79a7-3602-432f-a17b-99bb30556f6e 35 fields · synced May 30, 2026
  • FDA 510(k) K200694 1 fields · synced May 18, 2026