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FDA 510(k)

Otsuka Digital Feedback Device-RW

K-Number: K223463 · 2023-08-11

ApplicantOtsuka America Pharmaceutical, Inc.
Decision Date2023-08-11
Product CodeOZW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Otsuka Digital Feedback Device-RW is a medical device manufactured by Otsuka America Pharmaceutical, Inc.. It received FDA 510(k) clearance on 2023-08-11 under approval number K223463. The device is classified under product code OZW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Otsuka Digital Feedback Device-RW?

Otsuka Digital Feedback Device-RW is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by Otsuka America Pharmaceutical, Inc.. The 510(k) number is K223463.

When was Otsuka Digital Feedback Device-RW approved by the FDA?

Otsuka Digital Feedback Device-RW received FDA 510(k) clearance on 2023-08-11, under approval number K223463.

What company makes Otsuka Digital Feedback Device-RW?

Otsuka Digital Feedback Device-RW is manufactured by Otsuka America Pharmaceutical, Inc..

What is the FDA product code for Otsuka Digital Feedback Device-RW?

The FDA product code for Otsuka Digital Feedback Device-RW is OZW.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41844911 Toward global standards for SaMD: introducing a proposal for Good Digital Medicine Practices (GDMP). NPJ digital medicine (2026) PMID: 41702410 FDA 510(k) clearances for chronic pain devices: regulatory trends and safety outcomes from 1976-2025. Expert review of medical devices (2026)

Other Devices by Otsuka America Pharmaceutical, Inc.

K231209Rejoyn K251088Otsuka Digital Feedback Device

Related Devices (Code: OZW)

K183052ID-Cap SystemEtectrx, Inc. K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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