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FDA 510(k)

Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE

K-Number: K111278 · 2011-09-16

ApplicantOtto Bock Healthcare LP
Decision Date2011-09-16
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE 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 2011-09-16 under 510(k) number K111278. 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 Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE?

Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE is a medical device that received FDA 510(k) clearance on 2011-09-16. The listed applicant is Otto Bock Healthcare LP. The 510(k) number is K111278.

When did Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE receive FDA 510(k) clearance?

Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE received FDA 510(k) clearance on 2011-09-16, under 510(k) number K111278.

Who is the listed applicant for Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE?

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 Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE?

The FDA product code for Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE is ITI.

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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.

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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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