Data / Medical devices / United States / Innovative Neurotronics Inc.
Innovative Neurotronics Inc.: FDA-registered device maker in Reno, NV, United States, 3 510(k) clearances
Innovative Neurotronics Inc. is registered with the FDA (registration 3005694504) in Reno, NV, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 8, 2014. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005694504
- Address
- 1170 Trademark Dr Ste 104, Reno, NV, United States, 89521
- Owner or operator
- Innovative Neurotronics (9076839)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 25, 2006
- Registered through
- 2026
- Brand names listed
- IO Compliance Monitor Scoliosis Brace, V-Hold, WALKAIDE SYSTEM, WalkAide, WalkAide System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Joint, Knee, External Limb Component | ISY | 1 | Specification developer | accessdata.fda.gov |
| Monitor, Orthotic/Prosthetic | NHF | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Neuromuscular, External Functional | GZI | 2 | Manufacturer, Specification developer | 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 8, 2014 | K140886 | WALKAIDE SYSTEM | GZI | Substantially Equivalent | Innovative Neurotronics, Inc. | accessdata.fda.gov |
| April 1, 2013 | K123972 | WALKAIDE SYSTEM | GZI | Substantially Equivalent | Innovative Neurotronics, Inc. | accessdata.fda.gov |
| September 21, 2005 | K052329 | WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 | GZI | Substantially Equivalent | Innovative Neurotronics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 6, 2008 | 52049 | Not yet classified | Terminated | WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746. The WalkAide is a battery operated, single channel el | Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Orthotic/Prosthetic
- All makers of Stimulator, Neuromuscular, External Functional
- All makers of Joint, Knee, External Limb Component
Updated August 8, 2014. 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.