Cleared Traditional

K103791 - PHYSIOGLOVE ES WITH ECG ANALYSIS

K103791 is an FDA 510(k) clearance for PHYSIOGLOVE ES WITH ECG ANALYSIS, manufactured by Commwell , Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K103791 · Commwell , Ltd. · Cardiovascular device
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Oct 2011
Decision
298d
Days
Class 2
Risk

K103791 is an FDA 510(k) clearance for the PHYSIOGLOVE ES WITH ECG ANALYSIS. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Commwell , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on October 21, 2011 after a review of 298 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Commwell , Ltd. devices

FDA 510(k) Submission Details - K103791

510(k) Number K103791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2010
Decision Date October 21, 2011
Days to Decision 298 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 125d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 327
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