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FDA 510(k)

MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651

K-Number: K001252 · 2000-06-12

ApplicantMaxhealth Corp.
Decision Date2000-06-12
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 is the device name listed in this FDA 510(k) record. The listed applicant is Maxhealth Corp.. It received FDA 510(k) clearance on 2000-06-12 under 510(k) number K001252. 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 MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651?

MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 is a medical device that received FDA 510(k) clearance on 2000-06-12. The listed applicant is Maxhealth Corp.. The 510(k) number is K001252.

When did MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 receive FDA 510(k) clearance?

MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 received FDA 510(k) clearance on 2000-06-12, under 510(k) number K001252.

Who is the listed applicant for MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651?

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

What is the FDA product code for MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651?

The FDA product code for MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 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 Maxhealth Corp. 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.

K070176MAXHEALTH MECHANICAL WHEELCHAIR, K1

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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