Cleared Traditional

K211263 - Intrelief

K211263 is an FDA 510(k) clearance for Intrelief, manufactured by Easymed Instruments Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K211263 · Easymed Instruments Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
248d
Days
Class 2
Risk

K211263 is an FDA 510(k) clearance for the Intrelief. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Easymed Instruments Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on December 30, 2021 after a review of 248 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 Easymed Instruments Co., Ltd. devices

FDA 510(k) Submission Details - K211263

510(k) Number K211263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2021
Decision Date December 30, 2021
Days to Decision 248 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 148d · This submission: 248d
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 149
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K211263.
TENS & EMS Device
K213835 · Shenzhen Jian Feng Electronic Technology Co., Ltd. · Mar 2022
Well-Life TENS/EMS/Heating Stimulator
K213091 · Well-Life Healthcare Limited · Feb 2022
TENS & PMS (Model: SM9126)
K220150 · Hong Qiangxing (Shenzhen) Electronics Limited · Feb 2022
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
K212285 · Oriental Inspiration Limited · Dec 2021
Transcutaneous Electrical Nerve Stimulator
K210223 · Top-Rank Health Care Co., Ltd. · Dec 2021
Heat StimPlus
K212918 · Famidoc Technology Co., Ltd. · Dec 2021