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FDA 510(k)

REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800

K-Number: K001923 · 2000-08-25

ApplicantGendron, Inc.
Decision Date2000-08-25
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800 is the device name listed in this FDA 510(k) record. The listed applicant is Gendron, Inc.. It received FDA 510(k) clearance on 2000-08-25 under 510(k) number K001923. 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 REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800?

REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800 is a medical device that received FDA 510(k) clearance on 2000-08-25. The listed applicant is Gendron, Inc.. The 510(k) number is K001923.

When did REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800 receive FDA 510(k) clearance?

REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800 received FDA 510(k) clearance on 2000-08-25, under 510(k) number K001923.

Who is the listed applicant for REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800?

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

What is the FDA product code for REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800?

The FDA product code for REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800 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

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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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