Cleared Traditional

K031910 - STAINLESS STEEL AQUATIC WHEELCHAIR

K031910 is an FDA 510(k) clearance for STAINLESS STEEL AQUATIC WHEELCHAIR, manufactured by Db Perks & Associates , Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K031910 · Db Perks & Associates , Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
35d
Days
Class 1
Risk

K031910 is an FDA 510(k) clearance for the STAINLESS STEEL AQUATIC WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Db Perks & Associates , Ltd. (Issaquah, US). The FDA issued a Cleared decision on July 25, 2003 after a review of 35 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 - K031910

510(k) Number K031910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2003
Decision Date July 25, 2003
Days to Decision 35 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
81d faster than avg
Panel avg: 116d · This submission: 35d
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 Peers - IOR Wheelchair, Mechanical

All 465
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K031910.
MECHANICAL WHEEHCHAIR
K033141 · Pacific Medical Suppliers, Inc. · Oct 2003
RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,
K032402 · Convaid Products, Inc. · Sep 2003
SHOCKWAVE SUSPENSION WHEELCHAIR
K032123 · Per4max Medical, LLC · Jul 2003
BRODA MODEL 587 MANUAL WHEELCHAIR
K032133 · Broda Ent., Inc. · Jul 2003
CHUMP
K030017 · Colours 'N Motion · May 2003
GALAXY SERIES WHEELCHAIR
K023993 · Evermed Corp. · Dec 2002
K031910 · STAINLESS STEEL AQUATIC WHEELCHAIR
Download PDF FDA Summary Db Perks & Associates…