Medline Strider, Models Midi 3 and Midi 4
FDA 510(k) K032446 · Medline Industries, Inc.
510(k) numberK032446
Submission
- Device name
- Medline Strider, Models Midi 3 and Midi 4
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- August 8, 2003
- Decision date
- February 12, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- INI – Vehicle, Motorized 3-Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3800
- Specialty
- Physical Medicine
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Questions and answers
When was Medline Strider, Models Midi 3 and Midi 4 cleared by the FDA?
Medline Strider, Models Midi 3 and Midi 4 (K032446) received a 510(k) decision of Substantially Equivalent on February 12, 2004, 188 days after the submission was received.
What is the product code of K032446?
The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.