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EASYSTIM NMS-28

by Easy Med Instrument Co., Ltd.

510(k) K050921

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK050921 Date12 Dec 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

EASYSTIM NMS-28 is a basic dual channel muscular stimulation unit. It is suitable for use in either a professional environment or for personal use.

The device is supplied as a hardware unit and allows the user to change any parameters by selecting the free programme (G). It was cleared through the FDA 510(k) process under submission K050921 and is substantially equivalent to the predicate device TensCare Ultima NMS/EMS Model XL-A3.

Other devices from Easy Med Instrument Co., Ltd.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What type of stimulation does the EASYSTIM NMS-28 provide?

    It delivers muscular stimulation through two independent channels, allowing clinicians or users to treat multiple muscle groups simultaneously or to run separate programs on each channel.

  • Is the EASYSTIM NMS-28 intended for professional use, personal use, or both?

    The device is designed for both environments; it can be employed in a clinical setting for therapeutic applications or used at home by individuals who need personal muscle stimulation.

  • How is the EASYSTIM NMS-28 supplied and can the user adjust settings?

    The unit is provided as a complete hardware package. Users can modify any stimulation parameters by selecting the free programme (G), giving flexibility to tailor treatment protocols.

  • What regulatory pathway was used for the EASYSTIM NMS-28’s clearance?

    The device was cleared through the FDA 510(k) process (submission K050921) and was found substantially equivalent to the TensCare Ultima NMS/EMS Model XL‑A3, following an abbreviated review.

  • Does the EASYSTIM NMS-28 require any consumables or accessories for operation?

    The description only mentions the hardware unit; no specific consumables or disposable accessories are listed, implying the device functions without additional single‑use components.