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S-Patch CardioAI

by Wellysis Corp.

S-Patch CardioAI is a medical device (FDA Class II) made by Wellysis Corp., cleared under FDA 510(k) K254255 on 25 Sep 2026 and listed in FDA GUDID since 27 Oct 2026 (UDI-DI 08800159500060), active as of 9 Nov 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 9 Nov 2026

Documents

510(k) K254255

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800159500060 UDI-DI Date27 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK254255 Date25 Sep 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K254255 decided 25 Sep 2026 Active
  • FDA GUDID UDI-DI 08800159500060 listed 27 Oct 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K254255
  2. Listed FDA GUDID 08800159500060

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Electrocardiographic long-term ambulatory recording analyser application software
Model / reference
S-Patch CardioAI
Primary DI / UDI-DI
08800159500060
510(k) Number
FDA product code
DQK, DPS
GMDN term
Electrocardiographic long-term ambulatory recording analyser application software
Device class
Class II
Regulation number
870.1425, 870.2340
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DQK (Computer, Diagnostic, Programmable).

Other devices from Wellysis Corp.

  • S-Patch CardioAI

    Class II

  • S-Patch Ex

    Class IIa

  • S-Patch Ex 0

    Class II

  • S-Patch ExL 0

    Class II

See all devices from Wellysis Corp. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)