Data / Medical devices / United States / Alken, Inc. D/B/A Polhemus
Alken, Inc. D/B/A Polhemus: FDA-registered device maker in Colchester, VT, United States, 1 510(k) clearance
Alken, Inc. D/B/A Polhemus is registered with the FDA (registration 1000246715) in Colchester, VT, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 27, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000246715
- Address
- 40 Hercules Drive, Colchester, VT, United States, 05446
- Owner or operator
- Alken, Inc. d/b/a Polhemus (10028587)
- Roles
- Complaint file establishment, Contract manufacturer
- First device listed
- February 16, 2015
- Registered through
- 2026
- Brand names listed
- FastSCAN II
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthosis, Cranial | MVA | 2 | Complaint file establishment | accessdata.fda.gov |
| Orthosis, Cranial, Laser Scan | OAN | 2 | Complaint file establishment | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| January 27, 2009 | K081787 | CAMLAB CRANIAL ORTHOSIS HELMET | OAN | Substantially Equivalent | Biosculptor Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Cranial
- All makers of Orthosis, Cranial, Laser Scan
- All makers of System, X-Ray, Tomography, Computed
Updated January 27, 2009. 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.