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Medline Strider Maxi 3

by Medline Industries, Inc.

510(k) K041054

Medline Strider Maxi 3 is a medical device (FDA Class II; FDA product code INI, Vehicle, Motorized 3-Wheeled) made by Medline Industries, Inc., cleared under FDA 510(k) K041054 on 25 May 2004, active as of 22 Oct 2026. One FDA recall is linked to it.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK041054 Date25 May 2004ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0036-2007 FDA Unclassified (pre-2012) initiated 20 Jul 2006

    Under conditions of heavy use, signs of overheating of the main battery cables have been observed.

Timeline

2 dated events

  1. Cleared FDA 510(k) K041054
  2. Recall initiated FDA recalls Z-0036-2007

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  • Withdrawn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
INI
Device class
Class II
Regulation
21 CFR Part 890.3800
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code INI (Vehicle, Motorized 3-Wheeled).

Other devices from Medline Industries, Inc.

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