FDA Registration
Active
🇩🇪 Germany
ARTROMOT®-E2 Compact
Reg #: 3003238222
·
FEI: 3003238222
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MEDIREHA GmbH
- Registration Number
- 3003238222
- FEI Number
- 3003238222
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Am Laidhoelzle 2
- City
- Umkirch Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- DJO, LLC
- Operator Number
- 9015378
- Address
- 5919 Sea Otter Place, Suite 200
- City
- Carlsbad
- State
- CA
- Postal Code
- 92010
- Country
- US
- Correspondent
- Dave Hunter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2009-08-27 |
Proprietary Names
ARTROMOT®-E2 Compact
OptiFlex®-S
OptiFlex®-K1 Standard
OptiFlex®-K1 Comfort Chip
OptiFlex®-K1 Classic
ARTROMOT®-E2
ARTROMOT®-SP3 Comfort Chip
ARTROMOT® ACTIVE-K
ARTROMOT®-SP3 Comfort
ARTROMOT®-SP3 Standard
ARTROMOT®-S4
ARTROMOT®-SP3 Standard Chip
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)