Cleared Traditional

Perfect EMS

K200694 · Tenscare, Ltd. · Neurology

Jun 2021

Decision

444d

Days

Class 2

Risk

About This 510(k) Submission

K200694 is an FDA 510(k) clearance for the Perfect EMS, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Tenscare, Ltd. (Epsom, GB). The FDA issued a Cleared decision on June 4, 2021, 444 days after receiving the submission on March 17, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K200694 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 2020
Decision Date	June 04, 2021
Days to Decision	444 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

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