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FDA 510(k)

ORTHOFAB WHEELCHAIR

K-Number: K952675 · 1996-05-07

ApplicantOrthofab, Inc.
Decision Date1996-05-07
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOFAB WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Orthofab, Inc.. It received FDA 510(k) clearance on 1996-05-07 under 510(k) number K952675. 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 ORTHOFAB WHEELCHAIR?

ORTHOFAB WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1996-05-07. The listed applicant is Orthofab, Inc.. The 510(k) number is K952675.

When did ORTHOFAB WHEELCHAIR receive FDA 510(k) clearance?

ORTHOFAB WHEELCHAIR received FDA 510(k) clearance on 1996-05-07, under 510(k) number K952675.

Who is the listed applicant for ORTHOFAB WHEELCHAIR?

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

What is the FDA product code for ORTHOFAB WHEELCHAIR?

The FDA product code for ORTHOFAB WHEELCHAIR is ITI.

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Other records listing Orthofab, 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.

K962565POWERED WHEELCHAIRK950904ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)K950903ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)K884812KARMA-RS, KARMA-FS WHEELCHAIRSK860095DIGIKIT NONPNEUMATIC TOURNIQUETK852661APOLLO STERILE BLADES

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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

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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