Cleared Special

K050567 - HEALTH BUDDY APPLIANCE

K050567 is an FDA 510(k) clearance for HEALTH BUDDY APPLIANCE, manufactured by Health Hero Network, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Special 510(k) pathway after a 32-day FDA review.

K050567 · Health Hero Network, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
32d
Days
Class 2
Risk

K050567 is an FDA 510(k) clearance for the HEALTH BUDDY APPLIANCE. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Health Hero Network, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 5, 2005 after a review of 32 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 Health Hero Network, Inc. devices

FDA 510(k) Submission Details - K050567

510(k) Number K050567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2005
Decision Date April 05, 2005
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

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 75
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