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FDA 510(k)

DISCOVERY TMAX MANUAL WHEELCHAIR

K-Number: K113164 · 2013-03-11

ApplicantOtto Bock Healthcare LP
Decision Date2013-03-11
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DISCOVERY TMAX MANUAL 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 2013-03-11 under 510(k) number K113164. 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 DISCOVERY TMAX MANUAL WHEELCHAIR?

DISCOVERY TMAX MANUAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2013-03-11. The listed applicant is Otto Bock Healthcare LP. The 510(k) number is K113164.

When did DISCOVERY TMAX MANUAL WHEELCHAIR receive FDA 510(k) clearance?

DISCOVERY TMAX MANUAL WHEELCHAIR received FDA 510(k) clearance on 2013-03-11, under 510(k) number K113164.

Who is the listed applicant for DISCOVERY TMAX MANUAL 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 DISCOVERY TMAX MANUAL WHEELCHAIR?

The FDA product code for DISCOVERY TMAX MANUAL WHEELCHAIR is IOR.

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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.

K213587MyCRO BandK201426MyCRO BandK111278Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICEK111045CENTRO FAMILY OF MANUAL WHEELCHAIRSK101524C2000 POWERED WHEELCHAIRK082314BRAVORACER PEDIATRIC MANUAL WHEELCHAIR

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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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