Data / Medical devices / United States / Altivera Medical, Inc.

Altivera Medical, Inc.: FDA-registered device maker in Englewood, CO, United States, 7 510(k) clearances

Name: Altivera Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Altivera Medical, Inc. is registered with the FDA (registration 3017936974) in Englewood, CO, United States. It lists 12 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 27, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3017936974
Address: 14800 Grasslands Drive, Englewood, CO, United States, 80112
Owner or operator: ZYNEX MEDICAL, INC. (9028838)
Roles: Manufacturer, Repackager or relabeler
First device listed: December 12, 2007
Registered through: 2027
Brand names listed: CryoHeat Bundle, DynaComp, InWave, M-Wave, NeuroMove NM900, NexWave, Saunders Cervical Traction, TENSWave and more

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Traction, Non-Powered	HST	1	Repackager or relabeler	accessdata.fda.gov
Device, Biofeedback	HCC	2	Manufacturer	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Manufacturer	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Repackager or relabeler	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Repackager or relabeler	accessdata.fda.gov
Orthosis, Lumbo-Sacral	IPY	1	Repackager or relabeler	accessdata.fda.gov
Orthosis, Thoracic	IPT	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Water Circulating	ILO	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Electrical, Non-Implantable, For Incontinence	KPI	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 27, 2024	K241228	TENSWave	GZJ	Substantially Equivalent	Zynex Medical Officer	accessdata.fda.gov
January 26, 2024	K233485	M-Wave	IPF	Substantially Equivalent	Zynex Medical, Inc.	accessdata.fda.gov
December 5, 2022	K222669	Cryopush Cold Compression Device	IRP	Substantially Equivalent	Chengdu Cryo-Push Medical Technology Co.,Ltd	accessdata.fda.gov
August 5, 2020	K200351	PlasmaFlight	IRP	Substantially Equivalent	Manamed, Inc.	accessdata.fda.gov
August 24, 2012	K121820	INWAVE	KPI	Substantially Equivalent	Zynex Medical, Inc.	accessdata.fda.gov
September 20, 2011	K111279	NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM	IPF	Substantially Equivalent	Zynex Medical, Inc.	accessdata.fda.gov
November 8, 2001	K012885	NEUROMOVE NM900	IPF	Substantially Equivalent	Dan Med, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.