# Perfect EMS

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/perfect-ems-k-pems>
- Manufacturer: [TensCare Ltd](https://devicerts.com/manufacturers/tenscare-ltd) (United Kingdom)
- Device class: Class IIa (EU MDR); Class II (US FDA)
- FDA product code: NGX, NUH
- EMDN: Z12062801 MUSCLE REINFORCEMENT STIMULATORS FOR INNERVATED MUSCLES
- GMDN: Physical therapy transcutaneous neuromuscular electrical stimulation system (46573)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 5033435K00045ZL · UDI-DI 05033435131419 · registered 2024-06-04 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 05033435131419 · listed 2023-08-31 · status: Listed (GUDID: in commercial distribution)
- **510(k)** · FDA 510(k) · United States · K200694 · issued 2021-06-04 · status: Active

## Recalls

No recall on record.

## Identity

- Trade name: Perfect EMS [EUDAMED]; TensCare [FDA GUDID (AccessGUDID)]
- Generic name: Physical therapy transcutaneous neuromuscular electrical stimulation system [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: K-PEMS [EUDAMED, FDA GUDID (AccessGUDID)]; Perfect EMS [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 05033435131419 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 5033435K00045ZL [EUDAMED]
- 510(k) Number: K200694 [FDA GUDID (AccessGUDID)]
- FDA product code: NGX [FDA GUDID (AccessGUDID)]; NUH [FDA GUDID (AccessGUDID)]
- EMDN code: Z12062801 [EUDAMED]
- GMDN term: Physical therapy transcutaneous neuromuscular electrical stimulation system (46573) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 890.5850 [FDA GUDID (AccessGUDID)]; 882.5890 [FDA GUDID (AccessGUDID)]
- System or procedure pack: Procedure pack [EUDAMED]
- EU registration type: System or procedure pack [EUDAMED]
- 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]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Over-the-counter: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Perfect EMS, TensCare Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/perfect-ems-k-pems (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-24
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/perfect-ems-k-pems.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/perfect-ems-k-pems
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.