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FDA 510(k)

Otsuka Digital Feedback Device

K-Number: K251088 · 2025-06-30

ApplicantOtsuka America Pharmaceutical, Inc.
Decision Date2025-06-30
Product CodeOZW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Otsuka Digital Feedback Device is a medical device manufactured by Otsuka America Pharmaceutical, Inc.. It received FDA 510(k) clearance on 2025-06-30 under approval number K251088. 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?

Otsuka Digital Feedback Device is a medical device that received FDA 510(k) clearance on 2025-06-30. It is manufactured by Otsuka America Pharmaceutical, Inc.. The 510(k) number is K251088.

When was Otsuka Digital Feedback Device approved by the FDA?

Otsuka Digital Feedback Device received FDA 510(k) clearance on 2025-06-30, under approval number K251088.

What company makes Otsuka Digital Feedback Device?

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

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

The FDA product code for Otsuka Digital Feedback Device 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.

K223463Otsuka Digital Feedback Device-RW K231209Rejoyn

Related Devices (Code: OZW)

K183052ID-Cap SystemEtectrx, Inc. K223463Otsuka Digital Feedback Device-RWOtsuka 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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