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FDA 510(k)

PRO WALKER ML-300 FOLDABLE WHEELCHAIR

K-Number: K041337 · 2004-05-28

ApplicantPro Walker, Inc.
Decision Date2004-05-28
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PRO WALKER ML-300 FOLDABLE WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Pro Walker, Inc.. It received FDA 510(k) clearance on 2004-05-28 under 510(k) number K041337. 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 PRO WALKER ML-300 FOLDABLE WHEELCHAIR?

PRO WALKER ML-300 FOLDABLE WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is Pro Walker, Inc.. The 510(k) number is K041337.

When did PRO WALKER ML-300 FOLDABLE WHEELCHAIR receive FDA 510(k) clearance?

PRO WALKER ML-300 FOLDABLE WHEELCHAIR received FDA 510(k) clearance on 2004-05-28, under 510(k) number K041337.

Who is the listed applicant for PRO WALKER ML-300 FOLDABLE WHEELCHAIR?

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

What is the FDA product code for PRO WALKER ML-300 FOLDABLE WHEELCHAIR?

The FDA product code for PRO WALKER ML-300 FOLDABLE WHEELCHAIR 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 Pro Walker, 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.

K041336PRO WALKER PL-200 POWER 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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