Cleared Traditional

K122562 - E-TENG MODEL EOR 1

K122562 is an FDA 510(k) clearance for E-TENG MODEL EOR 1, manufactured by E-Teng Technology, Inc.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K122562 · E-Teng Technology, Inc. · Physical Medicine device
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Aug 2013
Decision
352d
Days
Class 2
Risk

K122562 is an FDA 510(k) clearance for the E-TENG MODEL EOR 1. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by E-Teng Technology, Inc. (Taichung, TW). The FDA issued a Cleared decision on August 9, 2013 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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. Elevated predicate reliance profile. 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.

View all E-Teng Technology, Inc. devices

FDA 510(k) Submission Details - K122562

510(k) Number K122562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2012
Decision Date August 09, 2013
Days to Decision 352 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 115d · This submission: 352d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPL Device Classification - Class 2, Special Controls

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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 - IPL Wheelchair, Standup

All 12
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K122562.
Modular Power Standing System
K191376 · Motion Concepts · Aug 2019
Quickie(r) Q700-UP M
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Action Trackstander models TR1816, TR1820, TR2016, and TR2020
K163451 · Action Manufacturing, Inc. · Jan 2018
RISER STANDUP WHEELCHAIR
K832696 · Imex Medical Systems, Inc. · Sep 1983
LEVO-STAND-UP WHEELCHAIR
K790265 · Marion Laboratories, Inc. · Feb 1979