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510(k) K231289

S-Patch Ex Wearable ECG Patch by Wellysis Corp. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2023
Date Received
May 4, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Wellysis Corp.

  • K233906 — S-Patch (S-Patch ExL) (February 16, 2024)

Other clearances for product code DSH

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  • K243650 — Zio® monitor (DFG0001) (August 15, 2025)
  • K243603 — AeviceMD (May 5, 2025)
  • K242583 — AT-Patch (ATP-C130/ATP-C70) (May 2, 2025)
  • K232670 — HiCardi+ H100 (September 20, 2024)
  • K233906 — S-Patch (S-Patch ExL) (February 16, 2024)
  • K231104 — ABPMpro (November 27, 2023)
  • K233110 — Carnation Ambulatory Monitor (November 22, 2023)
  • K230184 — Holter ECG and ABP System (September 25, 2023)
  • K223382 — AeviceMD (July 7, 2023)