Cleared Traditional

K052813 - FD TENS 2030, MODEL DFJ24T

K052813 is an FDA 510(k) clearance for FD TENS 2030, manufactured by Fuji Dynamics Limited. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K052813 · Fuji Dynamics Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
113d
Days
Class 2
Risk

K052813 is an FDA 510(k) clearance for the FD TENS 2030, MODEL DFJ24T. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Fuji Dynamics Limited (Kowloon, HK). The FDA issued a Cleared decision on January 25, 2006 after a review of 113 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K052813

510(k) Number K052813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2005
Decision Date January 25, 2006
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 149d · This submission: 113d
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 451
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K052813.
ELECTROPULSE
K051128 · Pain Relief Technologies · Mar 2006
MAGBODY DT-600
K053284 · Durtech System Corp. · Mar 2006
ES-160
K051020 · Lhasa Oms, Inc. · Feb 2006
SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
K052182 · Shian Jia Meei Enterprise Co., Ltd. · Nov 2005
BIO-STIM KIT
K050174 · Skylark Device & Systems Co., Ltd. · Sep 2005
E-STIM II
K050435 · Lhasa Oms, Inc. · Sep 2005
K052813 · FD TENS 2030, MODEL DFJ24T
Download PDF FDA Summary Fuji Dynamics Limited