# K223463: Otsuka Digital Feedback Device-RW

- Pathway: 510(k) (Traditional)
- Applicant: Otsuka America Pharmaceutical, Inc.
- Decided: Aug 11, 2023 after 268 days
- Product code: OZW (Ingestible Event Marker)
- Device class: 2
- Regulation: 21 CFR 880.6305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K963725 (1997). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150494: Proteus Digital Health Feedback Device, Proteus Digital Health, Inc. (2015) Summary page 4.
- K133263: Proteus Patch, Proteus Ingestible Sensor (Accessory), Proteus Digital Health, Inc. (2014) Summary page 4.

## Most influential descendants
- K251088: Otsuka Digital Feedback Device (2025), 0 descendants of its own

## Indications for use
The Otsuka Digital Feedback Device-RW consists of a miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and time-stamped patient-logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Otsuka Digital Feedback Device-RW is intended to log, track and trend intake times. When co-ingested with medication, the tracking and trending of intake times may be used as an aid to measure medication adherence. The Otsuka Digital Feedback Device-RW may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable, and enables unattended data collection for clinical and research applications.

Source page: https://510kreport.com/device/K223463
Methodology: https://510kreport.com/methodology