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FDA 510(k)

ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)

K-Number: K950904 · 1995-04-05

ApplicantOrthofab, Inc.
Decision Date1995-04-05
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) is the device name listed in this FDA 510(k) record. The listed applicant is Orthofab, Inc.. It received FDA 510(k) clearance on 1995-04-05 under 510(k) number K950904. 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 ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)?

ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) is a medical device that received FDA 510(k) clearance on 1995-04-05. The listed applicant is Orthofab, Inc.. The 510(k) number is K950904.

When did ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) receive FDA 510(k) clearance?

ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) received FDA 510(k) clearance on 1995-04-05, under 510(k) number K950904.

Who is the listed applicant for ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)?

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

What is the FDA product code for ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR)?

The FDA product code for ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) is IOR.

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Other records listing Orthofab, 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.

K962565POWERED WHEELCHAIRK952675ORTHOFAB WHEELCHAIRK950903ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR)K884812KARMA-RS, KARMA-FS WHEELCHAIRSK860095DIGIKIT NONPNEUMATIC TOURNIQUETK852661APOLLO STERILE BLADES

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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.

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