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FDA 510(k)

REGAIN STAND-UP WHEELCHAIR

K-Number: K946110 · 1995-02-01

ApplicantRegain, Inc.
Decision Date1995-02-01
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REGAIN STAND-UP WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Regain, Inc.. It received FDA 510(k) clearance on 1995-02-01 under 510(k) number K946110. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGAIN STAND-UP WHEELCHAIR?

REGAIN STAND-UP WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1995-02-01. The listed applicant is Regain, Inc.. The 510(k) number is K946110.

When did REGAIN STAND-UP WHEELCHAIR receive FDA 510(k) clearance?

REGAIN STAND-UP WHEELCHAIR received FDA 510(k) clearance on 1995-02-01, under 510(k) number K946110.

Who is the listed applicant for REGAIN STAND-UP WHEELCHAIR?

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

What is the FDA product code for REGAIN STAND-UP WHEELCHAIR?

The FDA product code for REGAIN STAND-UP WHEELCHAIR is IPL.

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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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