Foot Drop System (Model XFT-2001D)

Q: What is the product code of K162718?

The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.

FDA 510(k) K162718 · Shenzhen Xft Medical Limited

Substantially Equivalent

510(k) numberK162718

Submission

Device name: Foot Drop System (Model XFT-2001D)
Applicant: Shenzhen Xft Medical Limited
Shenzhen, CN
Received: September 29, 2016
Decision date: November 30, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GZI – Stimulator, Neuromuscular, External Functional
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5810
Specialty: Neurology

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K212149	MyndMove 2.0GZI · Traditional	Myndtec, Inc.	03/03/2022SE
K213622	Cionic Neural Sleeve NS-100GZI · Traditional	Cionic	02/14/2022SE
K202110	MStim Drop Model: LGT-233GZI · Traditional	Guangzhou Longest Science & Technology Co., Ltd.	11/05/2021SE

More from Guangzhou Longest Science & Technology Co., Ltd.

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K211094	Nerve and Muscle StimulatorIPF · Traditional	07/08/2021SE
K193276	Nerve and Muscle StimulatorGZI · Traditional	09/23/2020SE
K193275	Nerve and Muscle StimulatorIPF · Traditional	04/11/2020SE

Questions and answers

When was Foot Drop System (Model XFT-2001D) cleared by the FDA?

Foot Drop System (Model XFT-2001D) (K162718) received a 510(k) decision of Substantially Equivalent on November 30, 2017, 427 days after the submission was received.

What is the product code of K162718?

The FDA product code is GZI – Stimulator, Neuromuscular, External Functional, a Class II (moderate risk) device regulated under 21 CFR 882.5810.