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FDA 510(k)

C2000 POWERED WHEELCHAIR

K-Number: K101524 · 2010-09-29

ApplicantOtto Bock Healthcare LP
Decision Date2010-09-29
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

C2000 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 2010-09-29 under 510(k) number K101524. 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 C2000 POWERED WHEELCHAIR?

C2000 POWERED WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2010-09-29. The listed applicant is Otto Bock Healthcare LP. The 510(k) number is K101524.

When did C2000 POWERED WHEELCHAIR receive FDA 510(k) clearance?

C2000 POWERED WHEELCHAIR received FDA 510(k) clearance on 2010-09-29, under 510(k) number K101524.

Who is the listed applicant for C2000 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 C2000 POWERED WHEELCHAIR?

The FDA product code for C2000 POWERED WHEELCHAIR 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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