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Zippie 3 TS/SP Wheelchair/Stander

by Sunrise Medical Quickie Designs, Inc.

510(k) K920463

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920463 Date2 Apr 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IPL
Device Class
Class II
Regulation
21 CFR Part 890.3900
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a wheelchair and standup combination, classified as a Class II medical device under regulation number 890.3900. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway with K number K920463.

The device is manufactured by Sunrise Medical Quickie Designs, Inc. and is authorized for distribution in the United States. It is intended for use in physical medicine settings and is supplied as a non-sterile, reusable device. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.

Other devices from Sunrise Medical Quickie Designs, Inc.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ZIPPIE 3 TS/SP wheelchair stander combination device intended for?

    The ZIPPIE 3 TS/SP is intended for use in physical medicine settings as a combination wheelchair and standup device, based on its classification under regulation number 890.3900 and advisory committee assignment to Physical Medicine.

  • Is the ZIPPIE 3 TS/SP wheelchair stander sterile or single-use?

    The device is supplied as non-sterile and reusable, as explicitly stated in the description which notes it is intended for reuse and no sterility information is provided, indicating it is not designed for single-use applications.

  • How was the ZIPPIE 3 TS/SP wheelchair stander cleared for market distribution?

    The ZIPPIE 3 TS/SP was cleared via the traditional 510(k) pathway as substantially equivalent to a predicate device, with clearance granted under K number K920463 on April 2, 1992, following submission on January 27, 1992.