Cleared Traditional

Explorer Mini (K190682) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190682 · Permobil AB · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
346d
Days
Class 2
Risk

K190682 is an FDA 510(k) clearance for the Explorer Mini. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Permobil AB (Timra, SE). The FDA issued a Cleared decision on February 27, 2020 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Permobil AB devices

Submission Details

510(k) Number K190682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2019
Decision Date February 27, 2020
Days to Decision 346 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 115d · This submission: 346d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IPL Wheelchair, Standup

All 65
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K190682.
Walking rehabilitation training electric wheelchair (ZW518)
K243783 · Shenzhen Zuowei Technology Co., Ltd. · Mar 2025
Action Trackchair Hawk
K202728 · Action Manufacturing, Inc. · Feb 2022
ParaMotion
K203761 · Powerbasetec GmbH · Jan 2022
Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08
K191334 · Matia Robotics (Us), Inc. · May 2020
F5 Corpus VS
K191874 · Permobil AB · Oct 2019
UPnRIDE
K182257 · Upnride Robotics , Ltd. · Sep 2019