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FDA 510(k)

SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER

K-Number: K823175 · 1982-11-16

ApplicantKinetic Concepts, Inc.
Decision Date1982-11-16
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 1982-11-16 under 510(k) number K823175. 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 SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER?

SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER is a medical device that received FDA 510(k) clearance on 1982-11-16. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K823175.

When did SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER receive FDA 510(k) clearance?

SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER received FDA 510(k) clearance on 1982-11-16, under 510(k) number K823175.

Who is the listed applicant for SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER?

The FDA 510(k) record lists Kinetic Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER?

The FDA product code for SIDEWINDER OMNI WHEELCHAIR DIRECT/POWER 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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