Cleared Traditional

K190682 - Explorer Mini

K190682 is an FDA 510(k) clearance for Explorer Mini, manufactured by Permobil AB. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 346-day FDA review.

K190682 · Permobil AB · Physical Medicine device
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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

FDA 510(k) Submission Details - K190682

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.

IPL Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K190682.
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F5 Corpus VS
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UPnRIDE
K182257 · Upnride Robotics , Ltd. · Sep 2019
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K191376 · Motion Concepts · Aug 2019