Cleared Traditional

EMS/TENS Massager Device

K233040 · Shenzhen Imdk Medical Technology Co., Ltd. · Physical Medicine

Feb 2024

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K233040 is an FDA 510(k) clearance for the EMS/TENS Massager Device, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Shenzhen Imdk Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 12, 2024, 140 days after receiving the submission on September 25, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K233040 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2023
Decision Date	February 12, 2024
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
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