FDA Registration
Active
🇺🇸 United States
IsoTour mattress, Isotour pump (accessory), mattress extender (accessory), turn assist upgrade kit (accessory)
Reg #: 1831750
·
FEI: 1831750
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- STRYKER MEDICAL
- Registration Number
- 1831750
- FEI Number
- 1831750
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3800 E. CENTRE AVE.
- City
- Portage
- State
- MI
- ZIP
- 49002
- Country
- US
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 1992-12-15 |
Proprietary Names
IsoTour mattress, Isotour pump (accessory), mattress extender (accessory), turn assist upgrade kit (accessory)
IsoAir
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device