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FDA 510(k)

ALL TERRAIN WHEELCHAIR (ATW)

K-Number: K003048 · 2000-12-15

ApplicantRoll-Ability (Pty) , Ltd.
Decision Date2000-12-15
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ALL TERRAIN WHEELCHAIR (ATW) is the device name listed in this FDA 510(k) record. The listed applicant is Roll-Ability (Pty) , Ltd.. It received FDA 510(k) clearance on 2000-12-15 under 510(k) number K003048. 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 ALL TERRAIN WHEELCHAIR (ATW)?

ALL TERRAIN WHEELCHAIR (ATW) is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Roll-Ability (Pty) , Ltd.. The 510(k) number is K003048.

When did ALL TERRAIN WHEELCHAIR (ATW) receive FDA 510(k) clearance?

ALL TERRAIN WHEELCHAIR (ATW) received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003048.

Who is the listed applicant for ALL TERRAIN WHEELCHAIR (ATW)?

The FDA 510(k) record lists Roll-Ability (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALL TERRAIN WHEELCHAIR (ATW)?

The FDA product code for ALL TERRAIN WHEELCHAIR (ATW) 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 Roll-Ability (Pty) , Ltd. 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.

K001298J.A.G. LIGHTWEIGHT MANUAL 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.

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