Cleared Special

K063612 - MODIFICATION TO HEALTH BUDDY APPLIANCE

K063612 is an FDA 510(k) clearance for MODIFICATION TO 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 25-day FDA review.

K063612 · Health Hero Network, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
25d
Days
Class 2
Risk

K063612 is an FDA 510(k) clearance for the MODIFICATION TO HEALTH BUDDY APPLIANCE. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Health Hero Network, Inc. (Redwood City, US). The FDA issued a Cleared decision on December 29, 2006 after a review of 25 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.

FDA 510(k) Submission Details - K063612

510(k) Number K063612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2006
Decision Date December 29, 2006
Days to Decision 25 days
Submission Type Special
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
100d faster than avg
Panel avg: 125d · This submission: 25d
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 183
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K063612.
RTX3370
K071953 · Rtx Healthcare A/S · Aug 2007
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K071058 · Nihon Kohden America, Inc. · Jun 2007
MODIFICATION TO HEALTH BUDDY APPLIANCE
K070543 · Health Hero Network, Inc. · Mar 2007
PATIENT DATA HANDLER & DEVICES (PDH&D)
K063484 · Intermed Advisors, Inc. · Dec 2006
TELEMEDICINE SYSTEM MODEL VMS-01
K062662 · Medic4all (Israel) , Ltd. · Nov 2006
MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP)
K062127 · Medic4all (Israel) , Ltd. · Nov 2006