Data / Medical devices / United States / CIONIC Facility
CIONIC Facility: FDA-registered device maker in Scotts Valley, CA, United States, 3 510(k) clearances
CIONIC Facility is registered with the FDA (registration 3019892999) in Scotts Valley, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019892999
- Address
- 1500 Green Hills Rd Suite 109, Scotts Valley, CA, United States, 95066
- Owner or operator
- CIONIC (10082455)
- Roles
- Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 16, 2022
- Registered through
- 2026
- Brand names listed
- Cionic Neural Sleeve NS-100, Cionic Neural Sleeve NS-200
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Neuromuscular, External Functional | GZI | 2 | Manufacturer, Remanufacturer, Repackager or relabeler, 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 |
|---|---|---|---|---|---|---|
| May 2, 2025 | K243828 | CIONIC NEURAL SLEEVE (NS-200) | GZI | Substantially Equivalent | Cionic, Inc. | accessdata.fda.gov |
| July 21, 2022 | K221823 | Cionic Neural Sleeve NS-100 | GZI | Substantially Equivalent | Cionic | accessdata.fda.gov |
| February 14, 2022 | K213622 | Cionic Neural Sleeve NS-100 | GZI | Substantially Equivalent | Cionic | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Neuromuscular, External Functional
- All makers of Stimulator, Muscle, Powered
- All makers of Device, Biofeedback
Updated May 2, 2025. 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.