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510(k) K190682

Explorer Mini by Permobil AB — Product Code IPL

K190682 is an FDA 510(k) premarket notification submitted by Permobil AB for the device "Explorer Mini". The FDA issued a decision of Substantially Equivalent on February 27, 2020. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Permobil AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2020
Date Received
March 18, 2019
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 Permobil AB

  • K191874 — F5 Corpus VS (October 25, 2019)
  • K143180 — F3 (March 27, 2015)
  • K143014 — F5 (March 25, 2015)
  • K123290 — M300 & M400 (April 17, 2013)
  • K103477 — PERMOBIL M300 / M400 (March 3, 2011)
  • K081964 — K450 POWERED WHEELCHAIR (July 29, 2008)
  • K071650 — C350 POWERED WHEELCHAIR (September 12, 2007)
  • K041219 — ELECTRO (August 4, 2004)
  • K032765 — STREET (January 30, 2004)
  • K993406 — TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 (December 18, 2000)

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)
  • 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)
  • K150548 — Tek RMD (Tek Robotic Mobilization Device) (June 11, 2015)

FDA data resources