Data / Medical devices / United States / Eastern Cranial Affiliates
Eastern Cranial Affiliates: FDA-registered device maker in Fairfax, VA, United States, 1 510(k) clearance
Eastern Cranial Affiliates is registered with the FDA (registration 3005021665) in Fairfax, VA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 16, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005021665
- Address
- 10523 Main Street, Fairfax, VA, United States, 22030
- Owner or operator
- EASTERN CRANIAL AFFILIATES, LLC, DBA INFINITE TECHNOLOGIES O (9049723)
- Roles
- Manufacturer
- First device listed
- December 14, 2018
- Registered through
- 2026
- Brand names listed
- KidCap
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthosis, Cranial | MVA | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 16, 2018 | K180568 | KidCap | MVA | Substantially Equivalent | Eastern Cranial Affiliates, LLC | accessdata.fda.gov |
Compare with other makers
Updated October 16, 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.