Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1043533

FEI Number

1000222138

Entity Name

U.S. ORTHOTICS, INC.

City/State/Country

Tampa, FL, US

Establishment Address

8605 PALM RIVER RD, Tampa, FL 33619, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

U.S. ORTHOTICS, INC. (Owner Number: 1043533)

Owner / Operator Contact Address

8605 PALM RIVER RD., --, Tampa, FL 33619, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2024-04-24
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2024-04-24
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2001-11-09
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-04-24
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2024-04-24
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2001-11-09
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2024-04-24
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2001-11-09
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2024-04-24
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2001-11-09

Official Correspondent

SALEEM MUSALLAM

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

U.S. ORTHOTICS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1043533. Last updated year: 2026. Please use registration number 1043533 when referencing this establishment in official correspondence.