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FDA 510(k)

GS-220 HAND IMPAIRMENT EVALUATION SYSTEM

K-Number: K912526 · 1991-09-05

ApplicantJ-Tech, Inc.
Decision Date1991-09-05
Product CodeLBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GS-220 HAND IMPAIRMENT EVALUATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is J-Tech, Inc.. It received FDA 510(k) clearance on 1991-09-05 under 510(k) number K912526. The device is classified under product code LBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GS-220 HAND IMPAIRMENT EVALUATION SYSTEM?

GS-220 HAND IMPAIRMENT EVALUATION SYSTEM is a medical device that received FDA 510(k) clearance on 1991-09-05. The listed applicant is J-Tech, Inc.. The 510(k) number is K912526.

When did GS-220 HAND IMPAIRMENT EVALUATION SYSTEM receive FDA 510(k) clearance?

GS-220 HAND IMPAIRMENT EVALUATION SYSTEM received FDA 510(k) clearance on 1991-09-05, under 510(k) number K912526.

Who is the listed applicant for GS-220 HAND IMPAIRMENT EVALUATION SYSTEM?

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

What is the FDA product code for GS-220 HAND IMPAIRMENT EVALUATION SYSTEM?

The FDA product code for GS-220 HAND IMPAIRMENT EVALUATION SYSTEM is LBB.

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Other records listing J-Tech, 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.

K954737SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICEK954647INCLINOMETERK945630LARGE MUSCLE STRENGTH GAUGEK913587JTECH 50 SERIES CUTTING LOOP

Related Devices (Code: LBB)

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.

K162412Hoggan Scientific® microFET2™Hoggan Scientific, LLCK073154FACTS HAND AND PINCH GRIP COMBOGlobal Services Group, LLCK052309DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006Saehan Corp.K042889DYNAMOMETER - MODEL FCE AND MODEL MSCAmetekK012492KADANCE 2000Kada Research, Inc.K981730DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002Nk Biotechnical Corp.

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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