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FDA 510(k)

(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM

K-Number: K884723 · 1989-02-08

ApplicantGreenleaf Medical Systems, Inc.
Decision Date1989-02-08
Product CodeKQX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Greenleaf Medical Systems, Inc.. It received FDA 510(k) clearance on 1989-02-08 under 510(k) number K884723. The device is classified under product code KQX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM?

(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM is a medical device that received FDA 510(k) clearance on 1989-02-08. The listed applicant is Greenleaf Medical Systems, Inc.. The 510(k) number is K884723.

When did (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM receive FDA 510(k) clearance?

(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM received FDA 510(k) clearance on 1989-02-08, under 510(k) number K884723.

Who is the listed applicant for (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM?

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

What is the FDA product code for (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM?

The FDA product code for (DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM is KQX.

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 Greenleaf Medical Systems, 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.

K943929DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)K935757GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEMK893537GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM

Related Devices (Code: KQX)

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.

K011827ORTELIUS 800Orthoscan , Ltd.K971079INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWAREInterlogics, Inc.K9623773D-SPINESkill Technologies, Inc.K961212SPINAL TOUCHFasstechK954647INCLINOMETERJ-Tech, Inc.K943929DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)Greenleaf Medical Systems, 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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