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Everyway Z4

by Everyway Medical Instruments Co., Ltd.

Everyway Z4 is a Class II device made by Everyway Medical Instruments Co., Ltd., cleared under FDA 510(k) K251856 on 21 Nov 2025 and listed in FDA GUDID since 3 Dec 2025 (UDI-DI 04719871186039), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K251856

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04719871186039 UDI-DI Date3 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK251856 Date21 Nov 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251856 decided 21 Nov 2025 Active
  • FDA GUDID UDI-DI 04719871186039 listed 3 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251856
  2. Listed FDA GUDID 04719871186039

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Everyway
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
Z4
Primary DI / UDI-DI
04719871186039
510(k) Number
FDA product code
NUH, NGX
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
882.5890, 890.5850
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Cleared under the same submission (K251856)

Other devices from Everyway Medical Instruments Co., Ltd.

See all devices from Everyway Medical Instruments Co., Ltd. →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)