Cleared Traditional

K110068 - MODEL PM3030

K110068 is an FDA 510(k) clearance for MODEL PM3030, manufactured by Omron Healthcare, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K110068 · Omron Healthcare, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
332d
Days
Class 2
Risk

K110068 is an FDA 510(k) clearance for the MODEL PM3030. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 332 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 Omron Healthcare, Inc. devices

FDA 510(k) Submission Details - K110068

510(k) Number K110068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2011
Decision Date December 08, 2011
Days to Decision 332 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
184d slower than avg
Panel avg: 148d · This submission: 332d
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 175
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K110068.
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
LIFECARE ARM & LEG PAIN RELIEF SYSTEM
K112415 · Everyway Medical Instruments Co.,Ltd · Oct 2011
EVERYWAY LOW BACK PAIN RELIEF SYSTEM
K110716 · Everyway Medical Instruments Co.,Ltd · Oct 2011
CARE BACK PAIN RELIEF STIMULATOR
K110707 · Shenzhen Dongdixin Technology Co., Ltd. · Aug 2011