Cleared Traditional

K942508 - ROBO

K942508 is the FDA 510(k) clearance for ROBO by Permobil AB. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K942508 · Permobil AB · Physical Medicine device
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Nov 1994
Decision
165d
Days
Class 2
Risk

K942508 is an FDA 510(k) clearance for the ROBO. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Permobil AB (Timra, SE). The FDA issued a Cleared decision on November 7, 1994 after a review of 165 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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. Standard predicate reliance. 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.

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Submission Details

510(k) Number K942508 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 26, 1994
Decision Date November 07, 1994
Days to Decision 165 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 115d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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 - INI Vehicle, Motorized 3-wheeled

All 80
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K942508.
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
K030814 · Invacare Corp. · Mar 2003
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K010135 · Invacare Corp. · Feb 2001
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K992052 · Invacare Corp. · Aug 1999
TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER
K901586 · Invacare Corp. · Apr 1990
TRI-SCOOT FRONT WHEEL DRIVE POWERED SCOOTER
K900600 · Invacare Corp. · Feb 1990