Cleared Special

K073038 - CAREMATIX WELLNESS SYSTEM

K073038 is the FDA 510(k) clearance for CAREMATIX WELLNESS SYSTEM by Carematix, Inc.. It is a Class 2 Cardiovascular device (product code DRG) cleared through the Special 510(k) pathway after a 74-day FDA review.

K073038 · Carematix, Inc. · Cardiovascular device
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Jan 2008
Decision
74d
Days
Class 2
Risk

K073038 is an FDA 510(k) clearance for the CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Carematix, Inc. (Chicago, US). The FDA issued a Cleared decision on January 11, 2008 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Carematix, Inc. devices

Submission Details

510(k) Number K073038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2007
Decision Date January 11, 2008
Days to Decision 74 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 72
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