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FDA 510(k)

WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR

K-Number: K120405 · 2012-09-19

Decision Date2012-09-19
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Walk on Wheels Australia Pty, Ltd.. It received FDA 510(k) clearance on 2012-09-19 under 510(k) number K120405. 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 WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR?

WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2012-09-19. The listed applicant is Walk on Wheels Australia Pty, Ltd.. The 510(k) number is K120405.

When did WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR receive FDA 510(k) clearance?

WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR received FDA 510(k) clearance on 2012-09-19, under 510(k) number K120405.

Who is the listed applicant for WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR?

The FDA 510(k) record lists Walk on Wheels Australia Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR?

The FDA product code for WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR is ITI.

Related Clinical Trials

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.

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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