FDA Registration
Active
🇺🇸 United States
U.S. ORTHOTICS, INC.
Reg #: 1043533
·
FEI: 1000222138
·
Expires 2026
Products
12
Proprietary Names
385
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- U.S. ORTHOTICS, INC.
- Registration Number
- 1043533
- FEI Number
- 1000222138
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8605 PALM RIVER RD
- City
- Tampa
- State
- FL
- ZIP
- 33619
- Country
- US
Owner / Operator
- Firm Name
- U.S. ORTHOTICS, INC.
- Operator Number
- 1043533
- Address
- 8605 PALM RIVER RD., --
- City
- Tampa
- State
- FL
- Postal Code
- 33619
- Country
- US
- Correspondent
- SALEEM - MUSALLAM
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 2024-04-24 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2024-04-24 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2001-11-09 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2024-04-24 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2024-04-24 |
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2001-11-09 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2024-04-24 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2001-11-09 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2024-04-24 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2001-11-09 |
| Orthosis, Rib Fracture, Soft | IPX | Class 1 | Physical Medicine | No | 2001-11-09 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2001-11-09 |
Proprietary Names
S1C-5
S2B-4
S4B-2
S1B-2.5
S2B-1.5
S4C-1
S1C-00
S4N-2.5
S4N-4
S4B-5
S1C-0
S2C-1
S2N-1.5
S4C-2
S1C-1
S4N-5
S1B-5
S2C-1.5
S2B-3
S4C-2.5
S4C-4
S2B-2.5
S2C-0
S1C-3
S2B-2
S2C-4
S1B-4
S4C-1.5
S2C-3
S4C-3
S2N-1
S1C-4
S4B-4
S1B-3
S1B-1.5
S2C-2.5
S2N-2
S1B-2
S2C-2
S2B-1
S2B-0
S1C-1.5
S1C-2
S4N-3
S1N-2
S1C-2.5
S1N-2.5
OSB12-2.5-LW
OSB8-2.5-SW
OSB6-3.5-LW
OSB8-3-SB
OSB6-3-LB
OSB8-3-LW
OSB12-4-SW
OSB12-4-SB
OSB8-4-SB
HB-L
OSB8-2.5-SB
OSB12-4-LB
OSB6-4-SW
OSB8-2.5-LW
OSB6-3-SW
OSB4-3-LW
OSB8-2.5-LB
OSB6-2.5-SW
OSB6-2.5-LB
OSB10-2.5-LB
OSB12-3-LB
OSB6-3-SB
OSB4-2.5-SW
OSB10-4-SB
OSB10-3.5-LB
OSB6-4-LB
OSB8-4-LW
OSB6-3.5-SB
OSB10-2.5-SB
OSB6-3.5-LB
OSB8-3.5-LB
OSB12-3.5-LW
OSB10-3.5-LW
OSB8-4-LB
OSB6-2.5-SB
OSB8-4-SW
OSB12-3.5-SW
OSB8-3-LB
OSB8-3.5-SB
OSB6-4-LW
OSB8-3.5-SW
OSB10-2.5-LW
OSB12-3.5-LB
OSB10-4-LB
OSB6-3-LW
OSB10-3-LW
OSB10-3-LB
OSB6-2.5-LW
OSB6-3.5-SW
OSB6-4-SB
OSB8-3-SW
OSB12-4-LW
OSB10-4-SW
OSB10-3.5-SB
HB-XL
OSB10-2.5-SW
OSB12-3-LW
OSB12-3-SW
OSB8-3.5-LW
OSB10-3-SW
OSB10-S
OSB10-4-LW
OSB10-3.5-SW
HB-S
OSB12-2.5-LB
OSB4-2.5-LW
PAS-L
S110V-M
PAS-XL
S110V-S
S110V-XL
PAS-M
S110V-L
PAS-S
S110V-U
A5-L
A4-M
A5-XL
A5-S
A5-M
A4-L
A6-S
A6-L
A6-M
A4-S
A6-XL
A4-XL
KW7-XL
MBE-16
K5D-L
MBE-25
KJ-PS1-L-2XL
KW8-XS
K5A-XS
E1-M
KW6-3XL
K5D-2XL
PS3-S
KW7-2XL
K-964-2XL
KJ-PS1-R-2XL
KW8-4XL
PMBE-9
E1-SM
E2-S
PS3-M
KW8-XL
K-907-4XL
K5D-XL
KW8-2XL
PMBE-12
KW8-S
KW6-4XL
E2-XS
KJ-PS1-R-XL
E1-L
K-964-M
KJ-PS2-R-2XL
PS3-L
KW8-M
KJ-PS1-L-3XL
KJ-PS2-L-S
KJ-PS2-R-XL
KW7-M
KW8-L
KJ-PS1-L-L
K5A-XL
E2-XL
PS3-XL
K-907-L
KJ-PS1-R-3XL
KJ-PS2-R-3XL
KJ-PS1-L-S
E2-ML
KW7-L
K-907-S
K-964-L
E2-M
KJ-PS2-L-M
K-907-XL
K5A-2XL
KJ-PS2-R-M
K-907-2XL
KJ-PS2-L-L
KJ-PS1-R-L
KJ-PS1-L-M
KW6-XL
MBE-22
K-907-M
PS3-3XL
KW6-S
KW6-M
K-964-XL
K5D-S
K5D-M
PS3-2XL
KW7-3XL
KW7-S
MBE-19
KW8-3XL
E2-L
KJ-PS2-R-S
KJ-PS1-R-M
KJ-PS1-L-XL
K-907-3XL
KJ-PS2-R-L
KW6-L
KJ-PS2-L-2XL
KJ-PS2-L-XL
KW6-2XL
P1-L
1275-L
1275-S
P1-S
1276-M
P1-XL
1275-XL
1276-L
1275-M
P1-M
1276-S
P1-XS
1276-XL
EL9
CU2.5
CC3-XL
CU2
CC2-XL
CU3
CC2.5-S
CC3.5-M
CU4
CC2.5-L
CC4-S
CC3.5-S
CC2-L
CC4-M
CU3.5
CC3.5-XL
CC3.5-L
CC4-XL
CC2-M
CC3-M
CC4-L
PCU-2
PCU-1.5
CC2.5-XL
CC2.5-M
CC3-L
CC2-S
CC3-S
W11-R
W10-R
W11-L
80-D12-ML
XPA-12B-2XL
82-DX10-XL
XPA-10W-L
Pro-V3-3XL-N12
Pro-V ATE8
82-JX12-XL
82-DX10-2XL
XPA-12B-XL
XPA-8B-5XL
82-JX10-M
XPA-10B-XL
Pro-V3-S-N12
1200-L
80-D10-XL
82-JX8-S
XPA-8B-M
80-D10-ML
82-DX10-M
Pro-V3-M-N12
Pro-V ATE6
80-J12-L
80-J10-S
82-DX12-ML
XPA-12B-L
82-JX10-XL
82-JX8-XL
80-D12-3XL
82-JX10-L
XPA-8B-XL
80-D10-3XL
82-DX12-M
80-J12-XS
XPA-10W-5XL
Pro-V3-2XL-N12
82-DX12-XL
XPA-i10P-M
XPA-8B-3XL
XPA-8B-2XL
80-D12-XS
XPA-10W-S
82-JX12-M
82-JX8-3XL
XPA-10W-M
80-D12-M
80-J10-XL
80-D10-M
82-JX8-2XL
80-D12-XL
82-DX10-ML
Pro-V3-L-N12
XPA-12B-S
82-DX10-L
82-JX10-ML
82-JX12-2XL
XPA-10B-M
80-D12-S
Pro-V3-XL-N12
80-J10-3XL
1200-2XL
80-J10-ML
80-J12-ML
80-J12-3XL
82-DX10-S
80-J12-XL
XPA-10B-S
XPA-10B-XS
XPA-10B-2XL
82-JX8-ML
80-J10-M
80-J12-2XL
80-J12-S
82-JX12-3XL
80-J10-XS
XPA-12B-M
82-JX12-L
1200-S
XPA-8B-L
XPA-12B-4XL
XPA-10B-3XL
80-D10-2XL
82-DX10-3XL
1200-M
80-D10-L
80-D10-XS
XPA-10B-L
82-DX12-2XL
XPA-12B-5XL
1200-XL
XPA-10B-4XL
XPA-8B-S
80-J10-2XL
80-J10-L
80-D10-S
80-D12-2XL
XPA-12B-3XL
XPA-10W-2XL
82-JX8-L
80-J12-M
82-JX10-2XL
XPA-8B-4XL
80-D12-L
82-JX8-M
82-JX10-3XL
90-M101-U
90-M80-U
90-M81-U
90-M101-X
90-M121-X
90-M80-X
90-M81-X
90-M61-U
90-M61-X
90-M60-U
90-M121-U
PCSV-C
CS75-M
SM-150-U
PCSV-I
CS75-L
CS75-S
CS75-XL
CS75-2XL
CS75-XS
Establishment Types
Manufacture Medical Device