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S-Patch CardioAI

by Wellysis Corp.

510(k) K254255

S-Patch CardioAI is a medical device (FDA Class II; FDA product code DPS, Electrocardiograph) made by Wellysis Corp., cleared under FDA 510(k) K254255 on 25 Sep 2026, active as of 23 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK254255 Date25 Sep 2026ClearedStatusActive

Official records

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  • Withdrawn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
DPS
Device class
Class II
Regulation
21 CFR Part 870.2340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Devices cleared under K254255

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K254255
UDI-DISize and differences
S-Patch CardioAI
Wellysis Corp.
S-Patch CardioAI08800159500060 —On the market

Similar devices

Other devices filed under FDA product code DPS (Electrocardiograph).

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. →