Cleared Special

K041341 - GOLDEN SPYDER, MODEL GS-300

K041341 is an FDA 510(k) clearance for GOLDEN SPYDER, manufactured by Golden Technologies, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Special 510(k) pathway after a 14-day FDA review.

K041341 · Golden Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
14d
Days
Class 2
Risk

K041341 is an FDA 510(k) clearance for the GOLDEN SPYDER, MODEL GS-300. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Golden Technologies, Inc. (Old Forge, US). The FDA issued a Cleared decision on June 3, 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 890.3860 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K041341

510(k) Number K041341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2004
Decision Date June 03, 2004
Days to Decision 14 days
Submission Type Special
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
102d faster than avg
Panel avg: 116d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 598
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K041341.
KARMA POWER WHEELCHAIR, MODEL KP-25
K041678 · Karma Medical Products Co., Ltd. · Jul 2004
PRO WALKER PL-200 POWER WHEELCHAIR
K041336 · Pro Walker, Inc. · Jul 2004
INVACARE 3G TARSYS
K033819 · Invacare Corp. · Jun 2004
A&I POWER WHEELCHAIR, PC-401
K041190 · Well Success Biotech, Inc. · May 2004
POWERED WHEELCHAIR
K033142 · Nats Corp. · May 2004
NOMAD FROM DYNAMIS MOBILITY LTD.
K040457 · Dynamis Mobility , Ltd. · May 2004
K041341 · GOLDEN SPYDER, MODEL GS-300
Download PDF FDA Summary Golden Technologies, …