Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND

K-Number: K954131 · 1996-06-06

ApplicantHoveround Corp.
Decision Date1996-06-06
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND is the device name listed in this FDA 510(k) record. The listed applicant is Hoveround Corp.. It received FDA 510(k) clearance on 1996-06-06 under 510(k) number K954131. 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 HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND?

HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND is a medical device that received FDA 510(k) clearance on 1996-06-06. The listed applicant is Hoveround Corp.. The 510(k) number is K954131.

When did HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND receive FDA 510(k) clearance?

HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND received FDA 510(k) clearance on 1996-06-06, under 510(k) number K954131.

Who is the listed applicant for HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND?

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

What is the FDA product code for HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND?

The FDA product code for HOVEROUND POWER WHEELCHAIR OR HVR-200 BY HOVEROUND 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 Hoveround 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.

K122707HOVERROUND TEKNIQUEK122741HOVEROUND TEKNIQUEK100527HOVEROUND TEKNIQUE, MODEL HD-6K100350HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GTK093946HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2K090108HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR

View all 17 devices →

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.

↑