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)

ALANTE, BATTERY OPERATED POWER WHEELCHAIR

K-Number: K011153 · 2001-05-29

ApplicantGolden Technologies, Inc.
Decision Date2001-05-29
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ALANTE, BATTERY OPERATED POWER WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Golden Technologies, Inc.. It received FDA 510(k) clearance on 2001-05-29 under 510(k) number K011153. 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 ALANTE, BATTERY OPERATED POWER WHEELCHAIR?

ALANTE, BATTERY OPERATED POWER WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2001-05-29. The listed applicant is Golden Technologies, Inc.. The 510(k) number is K011153.

When did ALANTE, BATTERY OPERATED POWER WHEELCHAIR receive FDA 510(k) clearance?

ALANTE, BATTERY OPERATED POWER WHEELCHAIR received FDA 510(k) clearance on 2001-05-29, under 510(k) number K011153.

Who is the listed applicant for ALANTE, BATTERY OPERATED POWER WHEELCHAIR?

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

What is the FDA product code for ALANTE, BATTERY OPERATED POWER WHEELCHAIR?

The FDA product code for ALANTE, BATTERY OPERATED POWER WHEELCHAIR 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 Golden Technologies, 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.

K063162GOLDEN LITEWAYK041341GOLDEN SPYDER, MODEL GS-300K041025BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELEDK012258COMPANION MODEL 221, 321, 421K971043GOLDEN EAGLEK971050GOLDEN HAWK

View all 8 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.

↑