Data / Medical devices / United States / Neuro-Fitness LLC
Neuro-Fitness LLC: FDA-registered device maker in Fall City, WA, United States, 1 510(k) clearance
Neuro-Fitness LLC is registered with the FDA (registration 3005026995) in Fall City, WA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 5, 2007. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005026995
- Address
- 36002 SE 49th St, Fall City, WA, United States, 98024
- Owner or operator
- Neuro-Fitness LLC (9070004)
- Roles
- Specification developer
- First device listed
- January 16, 2008
- Registered through
- 2027
- Brand names listed
- Calm Ultra, Ces Ultra
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | QJQ | 2 | 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 |
|---|---|---|---|---|---|---|
| April 5, 2007 | K062284 | CES ULTRA | QJQ | Substantially Equivalent | Neuro-Fitness, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 29, 2007 | 45503 | Not yet classified | Terminated | CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024 | No FDA clearance for the.35Hz/.45Hz frequency option on device. | accessdata.fda.gov |
Compare with other makers
Updated April 8, 2008. 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.