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FDA 510(k)

CENTRO FAMILY OF MANUAL WHEELCHAIRS

K-Number: K111045 · 2011-07-15

ApplicantOtto Bock Healthcare LP
Decision Date2011-07-15
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CENTRO FAMILY OF MANUAL WHEELCHAIRS 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 2011-07-15 under 510(k) number K111045. 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 CENTRO FAMILY OF MANUAL WHEELCHAIRS?

CENTRO FAMILY OF MANUAL WHEELCHAIRS is a medical device that received FDA 510(k) clearance on 2011-07-15. The listed applicant is Otto Bock Healthcare LP. The 510(k) number is K111045.

When did CENTRO FAMILY OF MANUAL WHEELCHAIRS receive FDA 510(k) clearance?

CENTRO FAMILY OF MANUAL WHEELCHAIRS received FDA 510(k) clearance on 2011-07-15, under 510(k) number K111045.

Who is the listed applicant for CENTRO FAMILY OF MANUAL WHEELCHAIRS?

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 CENTRO FAMILY OF MANUAL WHEELCHAIRS?

The FDA product code for CENTRO FAMILY OF MANUAL WHEELCHAIRS is IOR.

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Other records listing Otto Bock Healthcare LP as applicant

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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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