Cleared Traditional

K211094 - Nerve and Muscle Stimulator (FDA 510(k) Clearance)

K211094 · Shenzhen Xft Medical Limited · Physical Medicine device

Jul 2021

Decision

87d

Days

Class 2

Risk

K211094 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 July 8, 2021, 87 days after receiving the submission on April 12, 2021.

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

Submission Details

510(k) Number	K211094 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 12, 2021
Decision Date	July 08, 2021
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF