Cleared Traditional

K052548 - UROK ROCKING WHEELCHAIR, MODEL 700-4XX

K052548 is an FDA 510(k) clearance for UROK ROCKING WHEELCHAIR, manufactured by Amg Medical, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K052548 · Amg Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
112d
Days
Class 1
Risk

K052548 is an FDA 510(k) clearance for the UROK ROCKING WHEELCHAIR, MODEL 700-4XX. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Amg Medical, Inc. (Montreal, Quebec, CA). The FDA issued a Cleared decision on January 6, 2006 after a review of 112 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K052548

510(k) Number K052548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2005
Decision Date January 06, 2006
Days to Decision 112 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
4d faster than avg
Panel avg: 116d · This submission: 112d
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 452
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K052548.
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K052681 · Otto Bock Healthcare LP · Oct 2005
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K052468 · Intco Metal Products (Zhenjiang) Co., Ltd. · Oct 2005
K052548 · UROK ROCKING WHEELCHAIR, MODEL 700-4XX
Download PDF FDA Summary Amg Medical, Inc.