ParaMotion

FDA 510(k) K203761 · Powerbasetec GmbH

Substantially Equivalent

510(k) numberK203761

Submission

Device name
ParaMotion
Applicant
Powerbasetec GmbH
Bodensee, DE
Received
December 23, 2020
Decision date
January 21, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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 ParaMotion cleared by the FDA?

ParaMotion (K203761) received a 510(k) decision of Substantially Equivalent on January 21, 2022, 394 days after the submission was received.

What is the product code of K203761?

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