Cleared Traditional

K102598 - HI-DOW-XP

K102598 is an FDA 510(k) clearance for HI-DOW-XP, manufactured by Hi-Dow International, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K102598 · Hi-Dow International, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
245d
Days
Class 2
Risk

K102598 is an FDA 510(k) clearance for the HI-DOW-XP. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Hi-Dow International, Inc. (St Louis, US). The FDA issued a Cleared decision on May 13, 2011 after a review of 245 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.

View all Hi-Dow International, Inc. devices

FDA 510(k) Submission Details - K102598

510(k) Number K102598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2010
Decision Date May 13, 2011
Days to Decision 245 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
97d slower than avg
Panel avg: 148d · This submission: 245d
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 158
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K102598.
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
PAIN BUDDY
K102051 · Biomedical Life Systems, Inc. · Jul 2011
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
K091757 · Well-Life Healthcare Limited · Feb 2010
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
K063660 · Well-Life Healthcare Limited · Feb 2007
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
K052785 · Well-Life Healthcare Limited · Mar 2006