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FDA 510(k)

DIGI SPORTLENS SYSTEM

K-Number: K921444 · 1992-07-13

ApplicantFitness Quest, Inc.
Decision Date1992-07-13
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DIGI SPORTLENS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fitness Quest, Inc.. It received FDA 510(k) clearance on 1992-07-13 under 510(k) number K921444. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGI SPORTLENS SYSTEM?

DIGI SPORTLENS SYSTEM is a medical device that received FDA 510(k) clearance on 1992-07-13. The listed applicant is Fitness Quest, Inc.. The 510(k) number is K921444.

When did DIGI SPORTLENS SYSTEM receive FDA 510(k) clearance?

DIGI SPORTLENS SYSTEM received FDA 510(k) clearance on 1992-07-13, under 510(k) number K921444.

Who is the listed applicant for DIGI SPORTLENS SYSTEM?

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

What is the FDA product code for DIGI SPORTLENS SYSTEM?

The FDA product code for DIGI SPORTLENS SYSTEM is HQY.

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 Fitness Quest, 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.

K914595PULSE RATE MONITOR

Related Devices (Code: HQY)

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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

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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