Data / Medical devices / Mexico / Invamex S.de R.L. De C.V.
Invamex S.de R.L. De C.V.: FDA-registered device maker in REYNOSA Tamaulipas, Mexico, 6 510(k) clearances
Invamex S.de R.L. De C.V. is registered with the FDA (registration 9616091) in REYNOSA Tamaulipas, Mexico. It lists 18 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 14, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9616091
- FEI number
- 1000253203
- Address
- Avenida el Puente S/N Parque Industrial el Puente Manimex, REYNOSA Tamaulipas, Mexico, C.P. 88783
- Owner or operator
- Invacare Corporation dba Invacare America (1525712)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- December 21, 1977
- Registered through
- 2026
- Brand names listed
- 120A, Dual Motor, Power Controller, 120A, Dual Motor, Power Controller with Lights and 2 Actuator Channels, 2-Channel Actuator Module, 2D Dynamic Footrest Hanger, 4-Channel Actuator Module, 4-Switch Proximity, 4-way expansion block (harness for expandable systems), 9000 Jymni Pediatric Manual Wheelchair and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| November 14, 2018 | K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | IOR | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| April 17, 2017 | K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair | IOR | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| March 16, 2006 | K060582 | INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR | IOR | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| August 4, 2000 | K002170 | MODEL 9000 PEDIATRIC WHEELCHAIR | IOR | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
| March 1, 1994 | K935398 | TRACER SERIES MANUAL WHEELCHAIRS | IOR | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
| May 19, 1988 | K881951 | RIDE-LITE 9000 SERIES WHEELCHAIR | IOR | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Aid, Transfer
- All makers of Lift, Patient, Non-Ac-Powered
- All makers of Wheelchair, Mechanical
- All makers of Accessories, Wheelchair
- All makers of Device, Anti-Tip, Wheelchair
- All makers of Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Updated November 14, 2018. 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.