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FDA 510(k)

HANDI-TRACTION

K-Number: K904862 · 1990-11-05

ApplicantHandi-Trak, Inc.
Decision Date1990-11-05
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HANDI-TRACTION is the device name listed in this FDA 510(k) record. The listed applicant is Handi-Trak, Inc.. It received FDA 510(k) clearance on 1990-11-05 under 510(k) number K904862. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDI-TRACTION?

HANDI-TRACTION is a medical device that received FDA 510(k) clearance on 1990-11-05. The listed applicant is Handi-Trak, Inc.. The 510(k) number is K904862.

When did HANDI-TRACTION receive FDA 510(k) clearance?

HANDI-TRACTION received FDA 510(k) clearance on 1990-11-05, under 510(k) number K904862.

Who is the listed applicant for HANDI-TRACTION?

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

What is the FDA product code for HANDI-TRACTION?

The FDA product code for HANDI-TRACTION is ITI.

Related Clinical Trials

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Other records listing Handi-Trak, 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.

K904913HANDI-TRAK WHEELCHAIR SNOW CHAINS

Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.

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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