Cleared Traditional

K192016 - SMOOV O10

K192016 is an FDA 510(k) clearance for SMOOV O10, manufactured by Alber GmbH. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K192016 · Alber GmbH · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
295d
Days
Class 2
Risk

K192016 is an FDA 510(k) clearance for the SMOOV O10. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Alber GmbH (Albstadt, DE). The FDA issued a Cleared decision on May 19, 2020 after a review of 295 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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.

View all Alber GmbH devices

FDA 510(k) Submission Details - K192016

510(k) Number K192016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date May 19, 2020
Days to Decision 295 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
180d slower than avg
Panel avg: 115d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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 - ITI Wheelchair, Powered

All 220
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K192016.
Electric wheelchair (Model: S7012)
K200857 · Dongguan Prestige Sporting Goods Co., Ltd. · Dec 2020
e-Motion M25
K192618 · Alber GmbH · Nov 2020
BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
K193599 · 21st Century Scientific, Inc. · Sep 2020
Solax Powered Wheelchair (Models: S7101, S7103)
K182400 · Dongguan Prestige Sporting Goods Co., Ltd. · Apr 2020
Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
K192216 · Invacare Corporation · Jan 2020
Solax Powered Wheelchair
K182576 · Dongguan Prestige Sporting Goods Co., Ltd. · May 2019