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SudoCheck HW4

by Medeia Inc

SudoCheck HW4 is a Class II device made by Medeia Inc, cleared under FDA 510(k) K150804 on 19 Oct 2015 and listed in FDA GUDID since 5 Feb 2025 (UDI-DI 08690020003024), 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) K150804

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 Number08690020003024 UDI-DI Date5 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150804 Date19 Oct 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150804 decided 19 Oct 2015 Active
  • FDA GUDID UDI-DI 08690020003024 listed 5 Feb 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K150804
  2. Listed FDA GUDID 08690020003024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SudoCheck
Generic name
Skin electrical conductance meter
Model / reference
HW4
Primary DI / UDI-DI
08690020003024
510(k) Number
FDA product code
GZO
GMDN term
Skin electrical conductance meter
Device class
Class II
Regulation number
882.1540
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Skin electrical conductance meter

Similar devices

Other devices filed under FDA product code GZO (Device, Galvanic Skin Response Measurement).

Other devices from Medeia Inc

See all devices from Medeia Inc →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)