Cleared Traditional

K062616 - WELLNESSPRO 2010

K062616 is an FDA 510(k) clearance for WELLNESSPRO 2010, manufactured by Intelsource Group, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K062616 · Intelsource Group, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
304d
Days
Class 2
Risk

K062616 is an FDA 510(k) clearance for the WELLNESSPRO 2010. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Intelsource Group, Inc. (Crofton, US). The FDA issued a Cleared decision on July 6, 2007 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Intelsource Group, Inc. devices

FDA 510(k) Submission Details - K062616

510(k) Number K062616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date July 06, 2007
Days to Decision 304 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
156d slower than avg
Panel avg: 148d · This submission: 304d
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 200
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K062616.
PRO TENS, MODEL WL-240 RX
K080304 · Well-Life Healthcare Limited · Jun 2008
PROSTIM 1000/2000
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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