REGAIN STAND-UP WHEELCHAIR— 510(k) K946110

Substantially Equivalent

Regain, Inc.

FDA 510(k) clearance K946110 for REGAIN STAND-UP WHEELCHAIR, Substantially Equivalent on 1995-02-01. Applicant: Regain, Inc.. Device class: 2.

Clearance details

Applicant: Regain, Inc.
Product code: Code IPL
Device class: Class 2
Regulation: 21 CFR 890.3900
Advisory panel: Physical Medicine
Date received: 1994-12-14
Decision date: 1995-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.