Cleared Traditional

K042304 - CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251

K042304 is an FDA 510(k) clearance for CHUNC JUNIOR MODEL# SM 242, manufactured by Spectris Technologies, Inc.. 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.

K042304 · Spectris Technologies, Inc. · Physical Medicine device
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Sep 2004
Decision
14d
Days
Class 1
Risk

K042304 is an FDA 510(k) clearance for the CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Spectris Technologies, Inc. (Rockford, US). The FDA issued a Cleared decision on September 8, 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 - K042304

510(k) Number K042304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2004
Decision Date September 08, 2004
Days to Decision 14 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
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
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 K042304.
TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR
K042652 · Taiwan King Strong Co., Ltd. · Nov 2004
LITESTREAM 500E
K042444 · Pride Mobility Products Corp. · Oct 2004
VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
K042401 · American Track Roadsters, Inc. · Oct 2004
SINON SN-L402 LIGHTWEIGHT WHEELCHAIR
K041465 · Sinon Corporation · Jul 2004
FS SERIES WHEELCHAIR
K041814 · Foshan Dongfang Medical Equipment Manufactory(Ltd) · Jul 2004
PRO WALKER ML-300 FOLDABLE WHEELCHAIR
K041337 · Pro Walker, Inc. · May 2004
K042304 · CHUNC JUNIOR MODEL# SM 242, CHUNC ADAPT MODEL# SM 251
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