Data / Medical devices / United States / Secured Ortho Manufacturing Of America, LLC
Secured Ortho Manufacturing Of America, LLC: FDA-registered device maker in Deer Park, NY, United States, 2 510(k) clearances
Secured Ortho Manufacturing Of America, LLC is registered with the FDA (registration 3014658541) in Deer Park, NY, United States. It lists 20 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 20, 2013. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3014658541
- Address
- 28 West Jefryn Boulevard, Suite C, Deer Park, NY, United States, 11729
- Owner or operator
- Secured Ortho Manufacturing of America, LLC (10057821)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 30, 2018
- Registered through
- 2026
- Brand names listed
- Secure Wear, ankle stirrup, arm sling, arm support, back brace, camwalker, cane, cast shoe and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Attachment, Commode, Wheelchair | INB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cane | IPS | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Chair, Adjustable, Mechanical | INN | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Cover, Limb | IPM | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Crutch | IPR | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Joint, Hip, External Brace | ITS | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Orthosis, Thoracic | IPT | 1 | Specification developer | accessdata.fda.gov |
| Shoe, Cast | IPG | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Specification developer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Splint, Hand, And Components | ILH | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stirrup, External Brace Component | ITC | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tips And Pads, Cane, Crutch And Walker | INP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | 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 |
|---|---|---|---|---|---|---|
| June 20, 2013 | K130722 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
| October 18, 2012 | K122499 | AIRCAST VENAFLOW ELITE SYSTEM | JOW | Substantially Equivalent | Djo, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Thoracic
- All makers of Stirrup, External Brace Component
- All makers of Cover, Limb
- All makers of Tips And Pads, Cane, Crutch And Walker
- All makers of Accessory, Surgical Apparel
- All makers of Joint, Knee, External Brace
Updated June 20, 2013. 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.