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FDA 510(k)

ORION II (HEAVY DUTY 350 LBS AND 500 LBS)

K-Number: K101277 · 2010-06-04

ApplicantFuture Mobility Healthcare, Inc.
Decision Date2010-06-04
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORION II (HEAVY DUTY 350 LBS AND 500 LBS) 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 2010-06-04 under 510(k) number K101277. 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 ORION II (HEAVY DUTY 350 LBS AND 500 LBS)?

ORION II (HEAVY DUTY 350 LBS AND 500 LBS) is a medical device that received FDA 510(k) clearance on 2010-06-04. The listed applicant is Future Mobility Healthcare, Inc.. The 510(k) number is K101277.

When did ORION II (HEAVY DUTY 350 LBS AND 500 LBS) receive FDA 510(k) clearance?

ORION II (HEAVY DUTY 350 LBS AND 500 LBS) received FDA 510(k) clearance on 2010-06-04, under 510(k) number K101277.

Who is the listed applicant for ORION II (HEAVY DUTY 350 LBS AND 500 LBS)?

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 ORION II (HEAVY DUTY 350 LBS AND 500 LBS)?

The FDA product code for ORION II (HEAVY DUTY 350 LBS AND 500 LBS) 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.

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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 ORIONK102031GALAXY LITEK061010FUTURE 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

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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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