Cleared Traditional

K041814 - FS SERIES WHEELCHAIR

K041814 is an FDA 510(k) clearance for FS SERIES WHEELCHAIR, manufactured by Foshan Dongfang Medical Equipment Manufactory(Ltd). The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K041814 · Foshan Dongfang Medical Equipment Manufactory(Ltd) · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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Jul 2004
Decision
14d
Days
Class 1
Risk

K041814 is an FDA 510(k) clearance for the FS SERIES WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Foshan Dongfang Medical Equipment Manufactory(Ltd) (Foshan, Guangdong Province, CN). The FDA issued a Cleared decision on July 20, 2004 after a review of 14 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K041814

510(k) Number K041814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2004
Decision Date July 20, 2004
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 116d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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

Tuv Rheinland of North America, Inc.
TAMAS BORSAI

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 465
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K041814.
VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
K042401 · American Track Roadsters, Inc. · Oct 2004
CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251
K042304 · Spectris Technologies, Inc. · Sep 2004
SINON SN-L402 LIGHTWEIGHT WHEELCHAIR
K041465 · Sinon Corporation · Jul 2004
PRO WALKER ML-300 FOLDABLE WHEELCHAIR
K041337 · Pro Walker, Inc. · May 2004
COMBI SELF PROPELLED SHOWER COMMODE
K040677 · Kjaerulff Rehabilitation A/S · May 2004
KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHT
K041072 · Invacare Corporation · May 2004

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K041814 · FS SERIES WHEELCHAIR
Download PDF FDA Summary Foshan Dongfang Medic…