Cleared Traditional

K060669 - MEDRELIEF ST SERIES

K060669 is an FDA 510(k) clearance for MEDRELIEF ST SERIES, manufactured by Healthonics, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K060669 · Healthonics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
213d
Days
Class 2
Risk

K060669 is an FDA 510(k) clearance for the MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Healthonics, Inc. (New Ellenton, US). The FDA issued a Cleared decision on October 13, 2006 after a review of 213 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Healthonics, Inc. devices

FDA 510(k) Submission Details - K060669

510(k) Number K060669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2006
Decision Date October 13, 2006
Days to Decision 213 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 148d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 Neurology devices follow this clearance model.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 151
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K060669.
PRO TENS, MODEL WL-240 RX
K080304 · Well-Life Healthcare Limited · Jun 2008
COMFY SERIES: EV-804, EV-805 & EV-806
K071951 · Everyway Medical Instruments Co.,Ltd · Sep 2007
SELECT TENS, MODEL 4600S
K061650 · Empi · Jan 2007
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
K061476 · Biomedical Life Systems, Inc. · Jul 2006
MODEL BMLS03-7
K042711 · Biomedical Life Systems, Inc. · Mar 2005
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
K041388 · Biomedical Life Systems, Inc. · Nov 2004