Cleared Traditional

K083677 - PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1

K083677 is an FDA 510(k) clearance for PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1, manufactured by Commwell , Ltd.. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K083677 · Commwell , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
89d
Days
Class 2
Risk

K083677 is an FDA 510(k) clearance for the PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Commwell , Ltd. (Washington, US). The FDA issued a Cleared decision on March 10, 2009 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Commwell , Ltd. devices

FDA 510(k) Submission Details - K083677

510(k) Number K083677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2008
Decision Date March 10, 2009
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 148
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