Cleared Traditional

K180852 - Manual Wheelchair

K180852 is an FDA 510(k) clearance for Manual Wheelchair, manufactured by Jiangyin Newrise Medical Equipment Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K180852 · Jiangyin Newrise Medical Equipment Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
333d
Days
Class 1
Risk

K180852 is an FDA 510(k) clearance for the Manual Wheelchair. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Jiangyin Newrise Medical Equipment Co., Ltd. (Jiangyin, CN). The FDA issued a Cleared decision on March 1, 2019 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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.

FDA 510(k) Submission Details - K180852

510(k) Number K180852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2018
Decision Date March 01, 2019
Days to Decision 333 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
217d slower than avg
Panel avg: 116d · This submission: 333d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IOR Wheelchair, Mechanical

All 466
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K180852.
Rowheels Revolution 1.0
K190699 · Rowheels, Inc. · May 2019
Manual Wheelchair W54
K180309 · Jiangsu Jumao Medical Equipment Co., Ltd. · May 2019
Element Pediatric Wheelchair
K182840 · Leggero, LLC · Apr 2019
Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
K181090 · Invacare Corporation · Nov 2018
AST Model MA012 and MS019 Rehab Wheelchair
K181795 · Sichuan Ast Medical Equipment Co., Ltd. · Sep 2018
Athena 190
K173360 · Medical Rehab Products, LLC · May 2018
K180852 · Manual Wheelchair
Download PDF FDA Summary Jiangyin Newrise Medi…