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Powerstand Stand-Up Wheelchair

by The Standing Co., Inc.

510(k) K032101

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032101 Date22 Jan 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0993-2014 FDA Class II initiated 16 May 13

    Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexshaft which corrects this problem is available at no charge.

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  • Withdrawn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

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