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510(k) K251088

Otsuka Digital Feedback Device by Otsuka America Pharmaceutical, Inc. — Product Code OZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2025
Date Received
April 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ingestible Event Marker
Device Class
Class II
Regulation Number
880.6305
Review Panel
CV
Submission Type

To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device

Other clearances by Otsuka America Pharmaceutical, Inc.

  • K231209 — Rejoyn (March 30, 2024)
  • K223463 — Otsuka Digital Feedback Device-RW (August 11, 2023)

Other clearances for product code OZW

  • K223463 — Otsuka Digital Feedback Device-RW (August 11, 2023)
  • K183052 — ID-Cap System (December 6, 2019)
  • K150494 — Proteus Digital Health Feedback Device (June 27, 2015)
  • K133263 — PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) (February 7, 2014)
  • K131524 — PROTEUS PATCH INCLUDING INGESTIBLE SENSOR (June 23, 2013)
  • K131009 — PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) (May 7, 2013)
  • DEN120011 — PROTEUS INGESTION CONFINMATION SYSTEMS (July 10, 2012)