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)

GALAXY LITE

K-Number: K102031 · 2010-10-20

ApplicantFuture Mobility Healthcare, Inc.
Decision Date2010-10-20
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GALAXY LITE is the device name listed in this FDA 510(k) record. The listed applicant is Future Mobility Healthcare, Inc.. It received FDA 510(k) clearance on 2010-10-20 under 510(k) number K102031. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALAXY LITE?

GALAXY LITE is a medical device that received FDA 510(k) clearance on 2010-10-20. The listed applicant is Future Mobility Healthcare, Inc.. The 510(k) number is K102031.

When did GALAXY LITE receive FDA 510(k) clearance?

GALAXY LITE received FDA 510(k) clearance on 2010-10-20, under 510(k) number K102031.

Who is the listed applicant for GALAXY LITE?

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

What is the FDA product code for GALAXY LITE?

The FDA product code for GALAXY LITE is IOR.

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 Future Mobility Healthcare, 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.

K130788CAPELLAK103073SUPER CHAIR FOR KIDS BY ORIONK101277ORION II (HEAVY DUTY 350 LBS AND 500 LBS)K061010FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO MECHANICAL WHEELCHAIR

Related Devices (Code: IOR)

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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply 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.

↑