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FDA 510(k)

MODIFIED DEVICE FOR SELF EXAMINATION OF EYES

K-Number: K863429 · 1987-01-20

ApplicantWheel Checkers
Decision Date1987-01-20
Product CodeHOQ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODIFIED DEVICE FOR SELF EXAMINATION OF EYES is the device name listed in this FDA 510(k) record. The listed applicant is Wheel Checkers. It received FDA 510(k) clearance on 1987-01-20 under 510(k) number K863429. The device is classified under product code HOQ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED DEVICE FOR SELF EXAMINATION OF EYES?

MODIFIED DEVICE FOR SELF EXAMINATION OF EYES is a medical device that received FDA 510(k) clearance on 1987-01-20. The listed applicant is Wheel Checkers. The 510(k) number is K863429.

When did MODIFIED DEVICE FOR SELF EXAMINATION OF EYES receive FDA 510(k) clearance?

MODIFIED DEVICE FOR SELF EXAMINATION OF EYES received FDA 510(k) clearance on 1987-01-20, under 510(k) number K863429.

Who is the listed applicant for MODIFIED DEVICE FOR SELF EXAMINATION OF EYES?

The FDA 510(k) record lists Wheel Checkers as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED DEVICE FOR SELF EXAMINATION OF EYES?

The FDA product code for MODIFIED DEVICE FOR SELF EXAMINATION OF EYES is HOQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Wheel Checkers as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K843702APPARATUS & METHODS SELF-EXAM OF EYE

Related Devices (Code: HOQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180895AlleyeOculocare Medical AGK121738MYVISIONTRACK(TM)Vital Art and Science IncorporatedK014044MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)Notal Vision, Inc.K874252KREDA DISCRichmond Products, Inc.K843227MACULAR FUNCTION ANALYZERDanek Medical, Inc.K843702APPARATUS & METHODS SELF-EXAM OF EYEWheel Checkers

Official Source

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

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