FDA Registration
Active
🇺🇸 United States
Position Health, LLC
Reg #: 1424774
·
FEI: 3003473196
·
Expires 2026
Products
7
Proprietary Names
10
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- Position Health, LLC
- Registration Number
- 1424774
- FEI Number
- 3003473196
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 736 North Western Avenue, Suite 314
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233096
Owner / Operator
- Firm Name
- Position Health, LLC
- Operator Number
- 10059354
- Address
- 736 North Western Avenue, Suite 314
- City
- Lake Forest
- State
- IL
- Postal Code
- 60045
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2019-06-07 |
| Component, Cast | LGF | Class 1 | Orthopedic | No | 2018-12-26 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2023-09-18 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2018-12-26 |
| Bed-Patient Activity Monitoring System | SBO | Class 1 | General Hospital | No | 2024-06-25 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2018-12-26 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2018-12-26 |
Proprietary Names
TurnAssist Premium Patient Repositioning System Turning Sheet
Cast Wedge
Position Health Classic Post-Op Shoe
AnkleTough
PRESSUREALERT Pressure Monitoring System
Gaitkeeper
Heel/Elbow Protector, Knee Separator, Ulnar Nerve Protector
HEELIFT (Suspension Boot), HEELIFT Glide, HEELIFT Classic, HEELIFT Traction, HEELIFT AFO, HEELIFT Anti Rotation Wedge
ELBOWLIFT Suspension Pad
TurnAssist Premium Patient Repositioning System Wedges (30 degree body support wedge)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device