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FDA 510(k)

TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0

K-Number: K993406 · 2000-12-18

ApplicantPermobil AB
Decision Date2000-12-18
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 is the device name listed in this FDA 510(k) record. The listed applicant is Permobil AB. It received FDA 510(k) clearance on 2000-12-18 under 510(k) number K993406. 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 TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0?

TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 is a medical device that received FDA 510(k) clearance on 2000-12-18. The listed applicant is Permobil AB. The 510(k) number is K993406.

When did TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 receive FDA 510(k) clearance?

TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 received FDA 510(k) clearance on 2000-12-18, under 510(k) number K993406.

Who is the listed applicant for TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0?

The FDA 510(k) record lists Permobil AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0?

The FDA product code for TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 is ITI.

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Other records listing Permobil AB as applicant

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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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