Cleared Traditional

K040966 - MODIFICATION TO CAREMATIX WELLNESS SYSTEM

K040966 is an FDA 510(k) clearance for MODIFICATION TO CAREMATIX WELLNESS SYSTEM, manufactured by Carematix, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K040966 · Carematix, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
49d
Days
Class 2
Risk

K040966 is an FDA 510(k) clearance for the MODIFICATION TO CAREMATIX WELLNESS SYSTEM. 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 June 2, 2004 after a review of 49 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. 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.

FDA 510(k) Submission Details - K040966

510(k) Number K040966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2004
Decision Date June 02, 2004
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

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 191
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K040966.
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K040966 · MODIFICATION TO CAREMATIX WELLNESS SYSTEM
Download PDF FDA Summary Carematix, Inc.