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FDA 510(k)

A-200 POWERED WHEELCHAIR

K-Number: K052706 · 2005-12-27

ApplicantOtto Bock Healthcare LP
Decision Date2005-12-27
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

A-200 POWERED WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Healthcare LP. It received FDA 510(k) clearance on 2005-12-27 under 510(k) number K052706. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-200 POWERED WHEELCHAIR?

A-200 POWERED WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2005-12-27. The listed applicant is Otto Bock Healthcare LP. The 510(k) number is K052706.

When did A-200 POWERED WHEELCHAIR receive FDA 510(k) clearance?

A-200 POWERED WHEELCHAIR received FDA 510(k) clearance on 2005-12-27, under 510(k) number K052706.

Who is the listed applicant for A-200 POWERED WHEELCHAIR?

The FDA 510(k) record lists Otto Bock Healthcare LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-200 POWERED WHEELCHAIR?

The FDA product code for A-200 POWERED WHEELCHAIR is ITI.

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Other records listing Otto Bock Healthcare LP 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.

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Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance 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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