Cleared Traditional

K113544 - ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER

K113544 is an FDA 510(k) clearance for ELECTRONIC PULSE MASSAGER TENS ELECTRON..., manufactured by Prospera Corporation. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K113544 · Prospera Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
239d
Days
Class 2
Risk

K113544 is an FDA 510(k) clearance for the ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Prospera Corporation (Pleasanton, US). The FDA issued a Cleared decision on July 27, 2012 after a review of 239 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.

FDA 510(k) Submission Details - K113544

510(k) Number K113544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2011
Decision Date July 27, 2012
Days to Decision 239 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
90d slower than avg
Panel avg: 149d · This submission: 239d
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 K113544.
WITOUCH PRO
K120398 · Hollywog, LLC · Aug 2012
SENSUS
K121184 · Neurometrix, Inc. · Aug 2012
ATOM 1 (MODEL: BRC 2200)
K121578 · Bioelectric Research Corporation · Jul 2012
GEMORE TENS SYSTEM
K120569 · Gemore Technology Co, Ltd. · Jul 2012
ULTIMA NEO
K120054 · Pain Management Technologies · Jun 2012
JIAJIAN TENS
K112288 · Wuxi Jiajian Medical Instrument Co., Ltd. · May 2012
K113544 · ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
Download PDF FDA Summary Prospera Corporation