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510(k) K102837

HIROLLER ELEVATING WHEELCHAIR by Max Mobility, LLC — Product Code IPL

K102837 is an FDA 510(k) premarket notification submitted by Max Mobility, LLC for the device "HIROLLER ELEVATING WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on December 23, 2010. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Max Mobility, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2010
Date Received
September 29, 2010
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

Other clearances by Max Mobility, LLC

  • K151199 — SmartDrive Wheelchair Power Assist (July 30, 2015)
  • K113621 — SMARTDRIVE WHEELCHAIR POWER-ASSIST (July 6, 2012)

Other clearances for product code IPL

  • K243783 — Walking rehabilitation training electric wheelchair (ZW518) (March 12, 2025)
  • K202728 — Action Trackchair Hawk (February 10, 2022)
  • K203761 — ParaMotion (January 21, 2022)
  • K191334 — Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04 (May 29, 2020)
  • K190682 — Explorer Mini (February 27, 2020)
  • K191874 — F5 Corpus VS (October 25, 2019)
  • K182257 — UPnRIDE (September 12, 2019)
  • K191376 — Modular Power Standing System (August 13, 2019)
  • K172384 — Quickie(r) Q700-UP M (January 16, 2018)
  • K163451 — Action Trackstander models TR1816, TR1820, TR2016, and TR2020 (January 12, 2018)

FDA data resources