Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017936974

FEI Number

3017936974

Entity Name

Altivera Medical, Inc.

City/State/Country

Englewood, CO, US

Establishment Address

14800 Grasslands Drive, Englewood, CO 80112, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZYNEX MEDICAL, INC. (Owner Number: 9028838)

Owner / Operator Contact Address

9655 Maroon Circle, Englewood, CO 80112, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012885

PMA Number

N/A

All Registered Proprietary Names

DynaComp TENSWave InWave NeuroMove NM900

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IRP	Massager, Powered Inflatable Tube	Physical Medicine	Class 2	890.5650	2024-06-11
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-06-11
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2024-10-21
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Gastroenterology, Urology	Class 2	876.5320	2012-12-27
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2007-12-12
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2007-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZYNEX MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1723686	Altivera Medical, Inc.	Denver, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242140	Jiale Health Technology Shenzhen Co., Ltd.	Air Compression Leg Massager (K-705)	2025-03-17
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K873418	Bodylog, Inc.	BODYLOG STRESS REDUCTION PACKAGE	1987-12-17

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3014834638	ZENITH TECHNICAL INNOVATIONS, LLC	Gurnee, IL, US
3002849858	CERAGEM CO., LTD.	Cheonan-si, Seobuk-gu Chungnam, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017936974. Last updated year: 2026. Please use registration number 3017936974 when referencing this establishment in official correspondence.