Cleared Traditional

K193275 - Nerve and Muscle Stimulator (FDA 510(k) Clearance)

K193275 · Shenzhen Xft Medical Limited · Physical Medicine device

Apr 2020

Decision

137d

Days

Class 2

Risk

K193275 is an FDA 510(k) clearance for the Nerve and Muscle Stimulator. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).

Submitted by Shenzhen Xft Medical Limited (Shenzhen, CN). The FDA issued a Cleared decision on April 11, 2020, 137 days after receiving the submission on November 26, 2019.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K193275 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 26, 2019
Decision Date	April 11, 2020
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF