Cleared Traditional

Intrelief

K211263 · Easymed Instruments Co., Ltd. · Neurology

Dec 2021

Decision

248d

Days

Class 2

Risk

About This 510(k) Submission

K211263 is an FDA 510(k) clearance for the Intrelief, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Easymed Instruments Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on December 30, 2021, 248 days after receiving the submission on April 26, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K211263 FDA.gov
FDA Decision	Cleared 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

Device Classification

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