Cleared Traditional

K182995 - Bariatric Power Positioning System (BPPS)

K182995 is an FDA 510(k) clearance for Bariatric Power Positioning System (BPPS), manufactured by Motion Concepts. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K182995 · Motion Concepts · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
129d
Days
Class 2
Risk

K182995 is an FDA 510(k) clearance for the Bariatric Power Positioning System (BPPS). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Motion Concepts (Concord, CA). The FDA issued a Cleared decision on March 8, 2019 after a review of 129 days - within the typical 510(k) review window.

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 Motion Concepts devices

FDA 510(k) Submission Details - K182995

510(k) Number K182995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2018
Decision Date March 08, 2019
Days to Decision 129 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
14d slower than avg
Panel avg: 115d · This submission: 129d
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 375
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K182995.
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
Wu's Powered Wheelchair
K181163 · Wu'S Tech Co., Ltd. · Feb 2019
Invacare TDX SP2-HD with Captain's Seat
K182946 · Invacare Corporation · Dec 2018
Action Trackchair
K181908 · Action Manufacturing, Inc. · Dec 2018