Zynex Medical Inc

FDA Filings

This page includes the latest FDA filings for Zynex Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1723686
• FEI Number: 3000214920
• Name: ZYNEX MEDICAL, INC.
• Owner & Operator: ZYNEX MEDICAL, INC.
• Contact Address: 9555 Maroon Circle ; Englewood CO 80112 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9555 Maroon Circle ; Englewood, CO 80112 US
• Establishment Type:
  • Manufacture Medical Device
  • Remanufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00852670007540 ZYNEX MEDICAL, INC.	M-Wave	2024-03-26
GUDID 00852670007045 ZYNEX MEDICAL, INC.	E-Wave	2023-06-15
GUDID 00852670007151 ZYNEX MEDICAL, INC.	CM-1500 Wrist Cuff	2021-02-05
GUDID 00852670007052 ZYNEX MEDICAL, INC.	InWave	2021-02-05
GUDID 00852670007038 ZYNEX MEDICAL, INC.	NeuroMove	2021-02-05
GUDID 00852670007021 ZYNEX MEDICAL, INC.	TruWave TENS	2021-02-05
GUDID 00852670007007 ZYNEX MEDICAL, INC.	NexWave	2021-02-05
PMN K191697 Zynex Medical, Inc.	Cardiac Monitor 1500	2020-02-21
GUDID 00852670007113 ZYNEX MEDICAL, INC.	Zynex Medical Electrodes	2018-11-01
GUDID 00852670007106 ZYNEX MEDICAL, INC.	Zynex Medical Electrodes	2018-11-01
GUDID 00852670007090 ZYNEX MEDICAL, INC.	Zynex Medical Electrodes	2018-11-01
GUDID 00852670007083 ZYNEX MEDICAL, INC.	Zynex Medical Electrodes	2018-11-01
GUDID 00852670007076 ZYNEX MEDICAL, INC.	Zynex Medical Electrodes	2018-11-01
PMN K914925 | HCC ZYNEX MEDICAL, INC.	NeuroSystem 4	2012-12-27
PMN K914925 | HCC ZYNEX MEDICAL, INC.	NeuroSystem 2	2012-12-27
PMN K914925 | HCC ZYNEX MEDICAL, INC.	NeuroDynamix 2/4	2012-12-27
PMN K914925 | HCC ZYNEX MEDICAL, INC.	NeuroDynamix 2/4/8	2012-12-27
PMN K914920 | HCC ZYNEX MEDICAL, INC.	NeuroSystem Biofeedback	2012-12-27
PMN K121820 | KPI ZYNEX MEDICAL, INC.	InWave	2012-12-27
PMN K111279 | LIH ZYNEX MEDICAL, INC.	NexWave	2012-12-27
PMN K111279 | IPF ZYNEX MEDICAL, INC.	NexWave	2012-12-27
PMN K111279 | GZJ ZYNEX MEDICAL, INC.	NexWave	2012-12-27
PMN K121820 ZYNEX MEDICAL, INC.	INWAVE	2012-08-24
PMN K111279 ZYNEX MEDICAL, INC.	NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM	2011-09-20
PMN K991241 | LIH ZYNEX MEDICAL, INC.	IF8000	2007-12-12
PMN K991241 | IPF ZYNEX MEDICAL, INC.	IF8000	2007-12-12
PMN K013210 | GZJ ZYNEX MEDICAL, INC.	TruWave	2007-12-12
PMN K012885 | IPF ZYNEX MEDICAL, INC.	NeuroMove NM900	2007-12-12
PMN K012885 | HCC ZYNEX MEDICAL, INC.	NeuroMove NM900	2007-12-12
PMN K010745 | IPF ZYNEX MEDICAL, INC.	E-Wave	2007-12-12

Related Finance Registrations

NCAGE Code	5BV76	ZYNEX MEDICAL, INC.
NCAGE Code	5Q195	ZYNEX MEDICAL, INC.
CAGE Code	5BV76	ZYNEX MEDICAL, INC.
CAGE Code	5Q195	ZYNEX MEDICAL, INC.
S.A.M. Registration	5Q195 [141582226]	ZYNEX MEDICAL, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018081537230	Shanghai ,China (Mainland) -> Los Angeles, California	ELECTRODE PAD	150 CTN