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FDA 510(k)

LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE

K-Number: K933633 · 1994-02-22

ApplicantGracefully Yours, Inc.
Decision Date1994-02-22
Product CodeHJG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE is the device name listed in this FDA 510(k) record. The listed applicant is Gracefully Yours, Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K933633. The device is classified under product code HJG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE?

LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Gracefully Yours, Inc.. The 510(k) number is K933633.

When did LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE receive FDA 510(k) clearance?

LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE received FDA 510(k) clearance on 1994-02-22, under 510(k) number K933633.

Who is the listed applicant for LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE?

The FDA 510(k) record lists Gracefully Yours, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE?

The FDA product code for LOW-VISION READING AID, HELPMATE 2020, VISION-AIDE, LV HELPMATE is HJG.

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 Gracefully Yours, Inc. 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.

K941659AURAL-CAM, VIDEO EAR, VID RX

Related Devices (Code: HJG)

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.

K915340MENTOR HORIZON LOW VISION MAGNIFIERMentor O & O, Inc.K920069MAGNI-CAMInnoventions, Inc.K892351MAGNILINK SYSTEM 602Coburn Optical Ind., Inc.K892350MAGNILINK SYSTEM 402/5Coburn Optical Ind., Inc.K892347MAGNILINK SYSTEM 101Coburn Optical Ind., Inc.K892348MAGNILINK SYSTEM 201Coburn Optical Ind., Inc.

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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