FDA Registration
Active
🇺🇸 United States
ALLARD USA INC.
Reg #: 3005282622
·
FEI: 3005282622
·
Expires 2026
Products
18
Proprietary Names
38
Establishment Types
2
Classifications
18
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Registration Details
- Registration Name
- ALLARD USA INC.
- Registration Number
- 3005282622
- FEI Number
- 3005282622
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 300 Forge Way Ste 3
- City
- ROCKAWAY
- State
- NJ
- ZIP
- 07866
- Country
- US
Owner / Operator
- Firm Name
- Allard Support for Better Life AB
- Operator Number
- 8030901
- Address
- 38 KARBINGATAN, --
- City
- HELSINGBORG
- State
- SE-NOTA
- Postal Code
- SE-254 67
- Country
- SE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Extremity, Inflatable, External | FZF | Class 1 | General, Plastic Surgery | No | 2010-07-30 |
| Orthosis, Sacroiliac, Soft | IPW | Class 1 | Physical Medicine | No | 2005-07-28 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2024-10-10 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2010-07-30 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2005-07-28 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2010-07-30 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2005-07-28 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2010-07-30 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2024-06-25 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2010-07-30 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2010-07-30 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2010-07-30 |
| Splint, Abduction, Congenital Hip Dislocation | IOZ | Class 1 | Physical Medicine | No | 2010-07-30 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2005-07-28 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2010-07-30 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2010-07-30 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2010-07-30 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2005-07-28 |
Proprietary Names
FORGE
CSUS
M2
VISSION
Vission
NAVY
Aosuo prosthetic foot shell
S.O.T
AND COMPONENTS
SELECTION
WRIST SPLINTS
LSO Xtra LSO+
MultiMotion
BINKY
Kid-Dee-Lite
Meracus One
COMBO
Combo
ToeOFF 2
BlueRocker
CHECK
KiddieRocker
KiddieGait
SWASH
ToeOFF
Ypsilon
ToeOFF FLOW 2 1/2
BlueRocker 2
Ypsilon FLOW 1/2
BlueROCKER 2 1/2
CROSS
KiddieFlow
ToeOFF 2 1/2
BLUEROCKER SHORT
ELEMENTS
Carbon Footplate
KiddieGAIT
HyMo
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198