POWERSTAND STAND-UP WHEELCHAIR— 510(k) K032101

Name: FDA 510(k) clearance K032101
Creator: U.S. Food and Drug Administration
Published: 2004-01-22

Substantially Equivalent

The Standing Co., Inc.

FDA 510(k) clearance K032101 for POWERSTAND STAND-UP WHEELCHAIR, Substantially Equivalent on 2004-01-22. Applicant: The Standing Co., Inc.. Device class: 2.

Clearance details

Applicant: The Standing Co., Inc.
Product code: Code IPL
Device class: Class 2
Regulation: 21 CFR 890.3900
Advisory panel: Physical Medicine
Date received: 2003-07-08
Decision date: 2004-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saginaw, MI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K032101

K-number listed on FDA's recall record

Z-0993-2014 — Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.Class II·Terminated·The Standing Company·20130516

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032101.

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