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FDA 510(k)

COMMUTER (MANUAL/POWER WHEELCLHAIR)

K-Number: K934232 · 1994-03-29

ApplicantFortress Lite-Style Wheelchairs, Inc.
Decision Date1994-03-29
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

COMMUTER (MANUAL/POWER WHEELCLHAIR) is the device name listed in this FDA 510(k) record. The listed applicant is Fortress Lite-Style Wheelchairs, Inc.. It received FDA 510(k) clearance on 1994-03-29 under 510(k) number K934232. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the COMMUTER (MANUAL/POWER WHEELCLHAIR)?

COMMUTER (MANUAL/POWER WHEELCLHAIR) is a medical device that received FDA 510(k) clearance on 1994-03-29. The listed applicant is Fortress Lite-Style Wheelchairs, Inc.. The 510(k) number is K934232.

When did COMMUTER (MANUAL/POWER WHEELCLHAIR) receive FDA 510(k) clearance?

COMMUTER (MANUAL/POWER WHEELCLHAIR) received FDA 510(k) clearance on 1994-03-29, under 510(k) number K934232.

Who is the listed applicant for COMMUTER (MANUAL/POWER WHEELCLHAIR)?

The FDA 510(k) record lists Fortress Lite-Style Wheelchairs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMMUTER (MANUAL/POWER WHEELCLHAIR)?

The FDA product code for COMMUTER (MANUAL/POWER WHEELCLHAIR) is ITI.

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 Fortress Lite-Style Wheelchairs, 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.

K934234VISION (MANUAL WHEELCHAIR)K934236LEGEND (MANUAL WHEELCHAIR)

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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