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FDA 510(k)

Diamond Digital Sleep Orthotic (DDSO)

K-Number: K202499 · 2020-09-03

ApplicantDiamond Orthotic Laboratory
Decision Date2020-09-03
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Diamond Digital Sleep Orthotic (DDSO) is a medical device manufactured by Diamond Orthotic Laboratory. It received FDA 510(k) clearance on 2020-09-03 under approval number K202499. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diamond Digital Sleep Orthotic (DDSO)?

Diamond Digital Sleep Orthotic (DDSO) is a medical device that received FDA 510(k) clearance on 2020-09-03. It is manufactured by Diamond Orthotic Laboratory. The 510(k) number is K202499.

When was Diamond Digital Sleep Orthotic (DDSO) approved by the FDA?

Diamond Digital Sleep Orthotic (DDSO) received FDA 510(k) clearance on 2020-09-03, under approval number K202499.

What company makes Diamond Digital Sleep Orthotic (DDSO)?

Diamond Digital Sleep Orthotic (DDSO) is manufactured by Diamond Orthotic Laboratory.

What is the FDA product code for Diamond Digital Sleep Orthotic (DDSO)?

The FDA product code for Diamond Digital Sleep Orthotic (DDSO) is LRK.

Related Clinical Trials

NCT07600840 Integrating Smart Wearable Device Into Digital Insomnia Treatment Application: Exploration of Combining Emotional and Lifestyle Records ENROLLING_BY_INVITATION NCT07589114 REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift RECRUITING NCT07582809 Clinical Investigation to Observe the Long-term Safety and Efficacy of the Digital Medical Device 'BELL-001' in Patients Diagnosed With Insomnia NOT_YET_RECRUITING NCT07558837 Fudan Tinnitus Doctor for Tinnitus Management NOT_YET_RECRUITING NCT06970171 Acceptance of Mandibular Advancement Devices ENROLLING_BY_INVITATION NCT07359638 Impact of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2 RECRUITING

Related PubMed Literature

PMID: 41429289 Clinical Evidence to Support US Food and Drug Administration Review of New Medical Technology in Pulmonary, Sleep, and Critical Care Medicine Between 2014 and 2024: A Scoping Review to Support Adoption in Practice. Chest (2026)

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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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