Hiroller Elevating Wheelchair

FDA 510(k) K102837 · Max Mobility, LLC

Substantially Equivalent

510(k) numberK102837

Submission

Device name
Hiroller Elevating Wheelchair
Applicant
Max Mobility, LLC
Antioch, TN, US
Received
September 29, 2010
Decision date
December 23, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IPL – Wheelchair, Standup
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3900
Specialty
Physical Medicine

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Questions and answers

When was Hiroller Elevating Wheelchair cleared by the FDA?

Hiroller Elevating Wheelchair (K102837) received a 510(k) decision of Substantially Equivalent on December 23, 2010, 85 days after the submission was received.

What is the product code of K102837?

The FDA product code is IPL – Wheelchair, Standup, a Class II (moderate risk) device regulated under 21 CFR 890.3900.