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510(k) K203761

ParaMotion by Powerbasetec GmbH — Product Code IPL

K203761 is an FDA 510(k) premarket notification submitted by Powerbasetec GmbH for the device "ParaMotion". The FDA issued a decision of Substantially Equivalent on January 21, 2022. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2022
Date Received
December 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Standup
Device Class
Class II
Regulation Number
890.3900
Review Panel
PM
Submission Type

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  • K191874 — F5 Corpus VS (October 25, 2019)
  • K182257 — UPnRIDE (September 12, 2019)
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  • K163451 — Action Trackstander models TR1816, TR1820, TR2016, and TR2020 (January 12, 2018)
  • K150548 — Tek RMD (Tek Robotic Mobilization Device) (June 11, 2015)

FDA data resources