Data / Medical devices / United States / Position Health, LLC
Position Health, LLC: FDA-registered device maker in Lake Forest, IL, United States, 1 510(k) clearance
Position Health, LLC is registered with the FDA (registration 1424774) in Lake Forest, IL, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1424774
- FEI number
- 3003473196
- Address
- 736 North Western Avenue, Suite 314, Lake Forest, IL, United States, 60045
- Owner or operator
- Position Health, LLC (10059354)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 26, 2018
- Registered through
- 2026
- Brand names listed
- AnkleTough, Cast Wedge, ELBOWLIFT Suspension Pad, Gaitkeeper, HEELIFT (Suspension Boot), HEELIFT Glide, HEELIFT Classic, HEELIFT Traction, HEELIFT AFO, HEELIFT Anti Rotation Wedge, Heel/Elbow Protector, Knee Separator, Ulnar Nerve Protector, PRESSUREALERT Pressure Monitoring System, Position Health Classic Post-Op Shoe and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bed-Patient Activity Monitoring System | SBO | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Component, Cast | LGF | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Components, Exercise | IOD | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthosis, Corrective Shoe | KNP | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Shoe, Cast | IPG | 1 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| June 21, 2024 | K233096 | PRESSUREALERT® Pressure Monitoring System | SBO | Substantially Equivalent | Position Health, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Shoe, Cast
- All makers of Components, Exercise
- All makers of Device, Transfer, Patient, Manual
- All makers of Component, Cast
- All makers of Protector, Skin Pressure
- All makers of Bed-Patient Activity Monitoring System
Updated June 21, 2024. 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.