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FDA 510(k)

POWER DRIVE WHEELCR

K-Number: K813104 · 1981-11-20

ApplicantIntl. Medical Equipment Corp.
Decision Date1981-11-20
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POWER DRIVE WHEELCR is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical Equipment Corp.. It received FDA 510(k) clearance on 1981-11-20 under 510(k) number K813104. 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 POWER DRIVE WHEELCR?

POWER DRIVE WHEELCR is a medical device that received FDA 510(k) clearance on 1981-11-20. The listed applicant is Intl. Medical Equipment Corp.. The 510(k) number is K813104.

When did POWER DRIVE WHEELCR receive FDA 510(k) clearance?

POWER DRIVE WHEELCR received FDA 510(k) clearance on 1981-11-20, under 510(k) number K813104.

Who is the listed applicant for POWER DRIVE WHEELCR?

The FDA 510(k) record lists Intl. Medical Equipment Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWER DRIVE WHEELCR?

The FDA product code for POWER DRIVE WHEELCR 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 Intl. Medical Equipment Corp. 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.

K832745OC3 FLYERK832321ACCES. HEAD CONTROL-POWERED CHEELCHAIRK832325BASE ONLY, POWER WHEELCHAIRK832322BASE ONLY, TORONTO CHAIRK803307MATTRESS, AIR FLOATATION, ALTERN. PRESS.

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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