Cleared Traditional

K113321 - TENS BACK PAIN RELIEF SYSTEM

K113321 is an FDA 510(k) clearance for TENS BACK PAIN RELIEF SYSTEM, manufactured by Savia Limited. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K113321 · Savia Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
299d
Days
Class 2
Risk

K113321 is an FDA 510(k) clearance for the TENS BACK PAIN RELIEF SYSTEM. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Savia Limited (Bonita Springs, US). The FDA issued a Cleared decision on September 4, 2012 after a review of 299 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 - K113321

510(k) Number K113321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2011
Decision Date September 04, 2012
Days to Decision 299 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
150d slower than avg
Panel avg: 149d · This submission: 299d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
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 - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 229
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K113321.
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
K122744 · Prospera Corporation · Mar 2013
HEALTHMATEFOREVER
K121757 · Healthmate International, LLC · Nov 2012
MINI PATCH
K121353 · Well-Life Healthcare Limited · Sep 2012
THE PAIN PILOT (A.K.A PAIN PILOT)
K120500 · Hollywog, LLC · Aug 2012
HIVOX BIOTEK INC.
K112392 · Hivox Biotek, Inc. · Mar 2012
PAIN-AID
K113037 · Pdi Works, LLC · Mar 2012
K113321 · TENS BACK PAIN RELIEF SYSTEM
Download PDF FDA Summary Savia Limited