Altivera Medical, Inc.
Denver, CO, US
Altivera Medical, Inc. appears in FDA device records in Denver, CO. FDA records list 5 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Altivera Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Zynex Medical, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 5 510(k) clearances for Altivera Medical, Inc. between 2011 and 2024. The busiest year on record is 2011, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2012 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233485 | M-Wave | IPF | Substantially Equivalent | |
| K223217 | Zynex Monitoring System, Model CM-1600 | DSB | Substantially Equivalent | |
| K191697 | Cardiac Monitor 1500 | DSB | Substantially Equivalent | |
| K121820 | INWAVE | KPI | Substantially Equivalent | |
| K111279 | NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM | IPF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1723686 | 3000214920 | Altivera Medical, Inc. | 8181 E Tufts Ave Ste 200, Denver, CO 80237 US | 2026 | |
| 3017936974 | 3017936974 | Altivera Medical, Inc. | 14800 Grasslands Drive, Englewood, CO 80112 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HSTApparatus, Traction, Non-Powered
- HCCDevice, Biofeedback
- LIHInterferential Current Therapy
- IRPMassager, Powered Inflatable Tube
- IQIOrthosis, Limb Brace
- IPYOrthosis, Lumbo-Sacral
- IPTOrthosis, Thoracic
- IMEPack, Hot Or Cold, Reusable
- ILOPack, Hot Or Cold, Water Circulating
- DSBPlethysmograph, Impedance
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1874-2014 | IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications. | Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Altivera Medical, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain