Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013002868

FEI Number

3013002868

Entity Name

BRACE ALIGN

City/State/Country

Soddy Daisy, TN, US

Establishment Address

128 Harrison Ln, Soddy Daisy, TN 37379, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Brace Align (Owner Number: 10052555)

Owner / Operator Contact Address

128 Harrison Lane, Soddy Daisy, TN 37379, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Brace Direct Deluxe Shoulder Immobilizer - ARS268 Brace Direct Arm Sling - ARS270 Brace Direct Foam Arm Sling Shoulder Immobilizer - ARS196-2 Brace Align Arm Sling and Swathe - ARS263 Brace Direct Pediatric Arm Sling - ARS265 Brace Direct Standard Shoulder Immobilizer Sling - ARS269 Brace Direct Immobilizer with Adbuctor - ARS167 Brace Direct Ossur Padded Strap Shoulder Immobilizer Sling - ARS494 Breg T Scope Premier Post-Op Knee Brace with BridgeTech Incision Pad by Brace Direct - KNB367-088 Breg T Scope BridgeTech Incision Pad Only by Brace Direct - KNB367-73621 Brace Align EasyStrap Unloader Knee Brace Straps 427 - ACS443 Breg T Scope Set of 4 Y-Tabs by Brace Direct - KNB367-00002 Brace Align Replacement Apex ACL Straps 428 - ACS444 Brace Direct Anti-Slip Strap for Knee Brace - KNW214 Breg T Scope Full Pad Replacement Kit by Brace Direct - KNB367-00015 Medical Lumbosacral Orthosis Back Brace by Brace Direct - BKB379 Breg Essentials Lumbar 631 Brace by Brace Direct - VP10631 Brace Direct BakTec 627 LSO Back Brace - BKB430 Brace Align Back Brace Extension Belt - BKB123-2 Brace Direct Lower Back Support Brace - BKB117 Brace Direct Rehabilitator LSO Back Brace - BKB120 Brace Align GlideFit SI Extension Panel - BKB434 Brace Align Adjustable LSO Back Brace - BKB121 Brace Align Core TLSO LSO Side Stays Side Panels - ACS435 Brace Direct LSO Back Brace for Lower Back Pain - BKB307 Brace Align VertebrAlign LSO Back Brace - BKB154 Brace Align VertebrAlign LSO Back Brace - BKB155 Brace Align Core Pro Plus LSO - BKB498 Brace Direct Core Lumbar Support Brace - BKB464 Brace Align VertebrAlign LSO II Medical Back Brace - BKB248 Brace Direct BakTec 650 LSO High Back Brace - BKB432 Brace Align VertebrAlign 51 LSO Back Brace - BKB499 Brace Direct Lower Back Support Brace - BKB287 Brace Align VertebrAlign LSO Lower Back Brace for Pain - BKB355 Brace Align GlideFit SI Belt - BKB420 Brace Direct Low Profile Lumbar Back Support Brace - BKB266 Brace Direct Back Brace Extension Belt - BKB122-2 Brace Align Core Pro LSO - BKB426 Brace Direct Contoured LSO Brace with Adjustable Lumbar Support - BKB281 Brace Align Rigid Anterior Panel Accessory for LSO - ACS470 Breg Essentials Lumbar 627 Brace by Brace Direct - VP10627 Breg Essentials Lumbar 637 Brace by Brace Direct - VP10637 Brace Align Ultra Light Air Short Full Shell Walking Boot - BTS278 Brace Align Carpal Tunnel Wrist Brace - WRB113 Brace Direct Cold Gel Tennis Elbow Brace - ARB199 Brace Align 90 Degree Night Splint - FTB257 Brace Direct 90 Degree Comfort Padded Night Splint - FTB-CL63-105 Brace Direct Immobilizer with Abductor - ARS167 Brace Direct Short Full Shell Walking Boot - BTS207 Brace Direct Pediatric Wrist Brace - WRB310 CMC Osteoarthritis Thumb Ring Brace - Bort by Brace Direct - WRW105-100 Brace Direct Wide Air Cam Fracture Boot Short - BTS222 Brace Direct Post Op Shoe - POS110 Brace Align PrecisionMotion ROM Wrist Brace - WRB436 Brace Direct Lycra Wrist Brace - WRB228 Brace Align Plantar Fasciitis Air Wrap - FTB259 Brace Align Air Cam Walker Fracture Short Boot - BTS104 VersaFit Wrist Brace - Breg by Brace Direct - WRB100639 Brace Direct Rom Cam Walker Tall - BTS-AD31 Brace Direct Deluxe Shoulder Immobilizer - ARS268 Brace Direct Carpal Tunnel Wrist Brace Night Splint - WRB303 Brace Align FlexRecover Hinged ROM Elbow Brace - EBB429 Brace Direct Plantar Fasciitis Posterior Night Splint - FTB133 Brace Direct Plantar Fasciitis Day Splint - FTW201 Brace Direct Deluxe Post Op Shoe - POS294 Brace Direct Mini Thumb Spica Splint - WRB166 Brace Align Wrist and Thumb Spica - WRB115 Brace Align ActivAir Walking Boot (Short) - BTS440 Brace Direct Tall Air Cam Walker Boot - BTS315 Brace Direct Pediatric Post Op Shoe - POST276 Brace Align ActivAir Walking Boot (Tall) - BTS441 Vectra Pro Walker Boot - Breg by Brace Direct - BTS469 Brace Align Stabilizing ROM Hinged Elbow Brace - EBB135 Brace Direct Plantar Fasciitis Pneumatic Foot Strap - PFD210 Brace Direct Lightweight Medical Full Shell Walking Boot with Air Pump - BTS297 Brace Direct Wide Air Cam Fracture Boot Tall - BTS219 Brace Direct Lightweight Medical Full Shell Walking Boot - BTS295 Brace Direct Wrist Splint with Thumb Spica - WRW111 Brace Direct Wide Cam Walker Fracture Boot Tall - BTS221 Universal Wrist Lacer Support Brace - Breg by Brace Direct - WRB380 Brace Direct Air Cam Fracture Boot - BTS-AD320 Brace Align Deluxe Post Op Shoe - POS223 Brace Align Cam Walker Fracture Boot Short - BTS119 Brace Align Pediatric Wrist Brace - WRB299 Brace Direct Plantar Fasciitis Premium Night Splint - FTB328 Brace Direct Wrist Support Brace - WRB106 Brace Direct Compression Brace for Tennis Elbow - KSP204 Brace Direct ROM Sprained Wrist Brace - WRB217 Brace Direct CAM Walker Fracture Boot Short - BTS116 Brace Direct Air Cam Walker Fracture Short Boot - BTS105 Brace Direct Pro Boxer Metacarpal Hand Fracture Splint - HNB463 Brace Direct CAM Walker Fracture Tall Boot - BTS103 Brace Align Air Cam Walker Fracture Boot Tall - BTS108 Brace Align Hybrid Night Splint - FTB158 Brace Direct ROM Post-Op Rehabilitation Elbow Brace - EBB136 Brace Direct Womens Short Air Walker Boot - BTS296 Brace Align Adjustable Night Splint - FTB255 Brace Align Deluxe Shoulder Brace - ARB-AD5100-E Brace Direct Hybrid Night Splint - FTB162 Brace Direct 90 Degree Night Splint - FTB132 Brace Direct Pediatric Wrist Splint - WRB274 Brace Direct ColorPop Wrist Kids Brace - WRB418 Brace Align Cam Walker Fracture Boot Tall - BTS107 Brace Align Childrens Post Op Shoe - POS313 Brace Align Dorsal Night Splint - NTS264 Brace Direct Wide Cam Walker Fracture Boot Short - BTS220 Brace Align 90 Degree Night Splint - FTB361 Brace Direct Adjustable Posterior Night Splint - FTB254 Brace Direct Short Air Cam Walker Boot - BTS357 Sport Elbow Compression Band - Bort by Brace Direct - ARB022500SP Brace Align StrideElite Leaf Spring AFO - FTB419 Brace Direct Dorsal Night Splint - NTS109 Brace Align Mini Thumb Spica Splint - WRW258 Brace Direct ROM Post Op Elbow Brace - EBB239 Brace Direct Air Cam Fracture Boot Tall - BTS118 Brace Direct Pediatric Wrist Brace - WRB209 Knit Elbow Compression Brace - Bort by Brace Direct - ARB122600 Brace Direct Premium Dorsal Night Splint - FTB241 Brace Direct Pediatric Walker Fracture Boot - BTS249 Brace Direct Digital Cervical Traction Unit with Massage/Heat/TENS - CTU377 Brace Direct Digital Cervical Traction Unit with Massage/Heat/TENS - CTU253 Brace Direct Digital Lumbar Traction Unit - LTU320 Brace Direct Neck Massager with Heat/Traction/TENS - CTU229 Brace Direct JumpStim TENS Muscle Stimulator - MTU458 Brace Direct Relief Pulse 5 TENS Unit by Ultima 5 - TNU456 Brace Direct OTC TENS Massager Unit by Ultima - TNU459 Brace Direct Digital Lumbar Traction - LTU251 Renewed Brace Direct Digital Cervical Traction Unit - UCTU348 Brace Direct Relief Pulse TENS Unit by Ultima 20 - TNU457 Brace Direct Digital Lumbar Traction Unit with Heat & Massage - LTU471 Brace Direct Digital Cervical Traction Unit - CTU348 Brace Align TLSO Thoracic Back Support Brace - BKB153 Brace Align ComfortCore TLSO - BKB427 Brace Direct Full Back Support Soft TLSO - BKB330 Brace Align VertebrAlign TLSO II Thoracic Medical Back Brace - BKB250 Brace Align TLSO Thoracic Back Support Brace - BKB271 Brace Align TLSO Thoracic Back Support Brace - BKB362 Brace Align TLSO Upper Back Support Brace - BKB169 Brace Align Core TLSO LSO Side Stays for Back Braces - ACS435 Brace Align Core VertebrAlign TLSO LSO Side Stays - ACS442 Brace Align TLSO Full Back Brace - BKB312 Brace Align Postural Correcting TLSO Back Brace - BKB175 Brace Direct Posture Back Brace TLSO - BKB170 Brace Direct Alternating Pressure Mattress - ACS225 Brace Align VertebrAlign TLSO LSO Side Stays - ACS442 Brace Direct Cervical Air Traction Collar - CRC289 Brace Direct Cervical Air Traction 2 Collar - CRC288 Ottobock Minerva Orthosis Cervical Thoracic Brace By Brace Direct - BKB364 Brace Align Cervical Neck Traction Collar - CNC401 Brace Direct Cervical Neck Traction Collar - CNC193 Brace Direct Soft Cervical Collar - CRC321 Renewed Brace Direct Pressure Modulating Wheelchair Cushion - UACS227 Brace Direct Alternating Pressure Wheelchair Cushion - ACS227 Brace Direct Cold Compression Knee Wrap - CTY178-2 Brace Direct Cryotherapy Air Pump Ankle Foot Wrap - CTY181-2 Brace Direct Knee Ice Pack Wrap with Compression - CTY282 Brace Direct Shoulder Ice Pack with Compression - CTY179 Brace Direct Ice Pack for Back with Compression - CTY180 Brace Direct Wrist Ice Pack Wrap with Compression - CTY183 Brace Direct Reusable Refreezable Extra Large Plastic Ice Cubes - ACS409 Brace Direct Ice Pack for Thigh with Compression - CTY182 Brace Direct Elbow Ice Wrap with Compression - CTY184-2 Brace Direct Reusable Refreezable Extra Large Plastic Ice Cubes - ACS381 Brace Direct Ice Pack for Knee Pain & Swelling - ACS168 Brace Direct Calf Ice Pack Wrap with Compression - CTY195 Brace Direct Back Brace Hot or Cold Therapy Pack - ACS447 Brace Direct Cryotherapy Air Pump Hip Wrap - CTY185-2 Brace Direct Back Ice Pack Insert for Back Braces - ACS236 Brace Direct Ankle & Foot Gel Ice Pack - ACS272 Brace Direct Air Cushion Ankle Brace - AKB172 Brace Direct In-Motion Ankle Brace - AKB191 Brace Direct Recovery Ankle Brace - AKB215 Brace Direct Air Stirrup Ankle Brace - AKB172-2 Brace Align Semi-Rigid Active Ankle Brace - AKB260 Breg by Brace Direct Ultra CTS Ankle Brace - BTS314 Brace Direct Semi-Rigid Active Ankle Brace - AKB134 Brace Direct Lace Up Ankle Brace - AKB177 Brace Direct Easy Lace Up Ankle Brace - AKB309 Elite Rehabilitator Varus/Valgus Ankle Control Strap - ACS286 Brace Direct Gel Air Ankle Brace - AKB173-2 Brace Direct Sport Ankle Compression Sleeve - AKB-CL67-200 Brace Align Ankle Brace - AKB176 TaloStabil Sport Ankle Compression Brace with Figure 8 Strap - Bort by Brace Direct - ASK054100SP Brace Direct Cervical Traction Device & Neck Stretcher - CTU411 Brace Direct Cervical Traction Unit Comfort Accessory Kit - ACS415 Renewed Brace Direct Cervical Air Traction Collar - UCNC193 Renewed Brace Direct Cervical Traction and Stretch Unit - UCTU138 Brace Direct Cervical Traction Unit - CTU174 Therahab Cervical Neck Traction Unit - CTU366 Brace Direct Cervical Neck Traction Unit - CTU138-2 Brace Align Portable Cervical Neck Traction Device - CTU203 Brace Direct Digital Cervical Traction Unit - CTU418 Brace Align Portable Cervical Traction Unit - CTU161 Brace Direct Cervical Neck Traction Collar - CNC193 Brace Direct Cervical Air Traction Collar - CRC289 Renewed Brace Direct Cervical Neck Traction Unit - UCTU359 Brace Direct Cervical Traction Device - CTU414 Brace Direct Home Cervical Traction Device - CTU359 Brace Direct Carbon Fiber AFO - FTB-CL-CK289 Brace Direct Leaf Spring AFO - FTB212 Brace Align Swedish Leaf Spring AFO - FTB302 Brace Direct StrideElite Leaf Spring AFO FTB419 Replacement Boot Liner Standard Short Walking Boot - ACS465 Brace Direct LevelUp - Walking Boot & Post-Op Shoe Leveler - FTB363 Brace Direct Replacement Sock Liner - ACS137 Brace Direct Recovery Ankle Extender - AKB218 Replacement Boot Liner Standard Tall Walking Boot - ACS466 Brace Direct Replacement Foam Wedge for 90 Degree Night Splint - ACS352 Brace Direct GreenRelief Silicone Cups - SHC421 SoftPro HKO Hip Abduction Orthosis L1652 - OCSI by Brace Direct - HPB344 Brace Direct Back Brace Extension Belt - BKB122 Brace Align GlideFit SI Extension Panel - BKB434 Brace Direct SI Joint Belt - BKB-CL-SI-100 Brace Align GlideFit SI Belt - BKB420 Brace Align Back Brace Extension Belt - BKB123 Brace Direct Rehabilitating Infrared Knee Recovery Massage Therapy Unit - KMT240 Brace Direct Red Light Therapy Knee Massage Unit - KMT246 Brace Direct Rehabilitating Infrared Knee Joint Massage Therapy Unit - KMT192 Brace Direct Cold Therapy Pads for BlueIce Cryotherapy Unit - ACS383 Brace Direct Cold Therapy Pads for FrozenHeat and FrozenIce Cold Therapy Machines - ACS460 Renewed Brace Direct Thermal Rehabilitation Device - UCTY326 Brace Direct IcedHeat Hot and Cold Water Circulating Machine - CTY408 Brace Direct Digital Frozen Heat Therapy Unit - CTY159 Brace Direct Frozen Ice Cold Therapy Machine - CTY194 Brace Direct Cryo-Compression Recovery System - CTY206 Renewed Brace Direct Knee Ice Machine - UCTY194 Brace Align Hot and Cold Therapy Unit - CTY226 Brace Direct Blue Ice Cold Therapy Machine - CTY243 Brace Direct Frozen Heat Therapy Unit - CTY326 Brace Direct Cold Compression Wrap Pro for Lower Leg - CTY232 Brace Direct Digital Frozen Heat Hot and Cold Water Therapy Machine - CTY407 Brace Direct IcedHeat Hot and Cold Therapy Machine - CTY244 Renewed Brace Direct Thermal Rehab Machine - UCTY159

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2024-02-06
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2026-04-27
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2016-08-15
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2016-08-19
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2021-01-15
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2024-02-06
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2021-05-12
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2025-09-12
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2021-01-15
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2026-04-28
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-02-06
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2024-02-06
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2021-05-12
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2026-04-28
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2025-09-11
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2026-04-28
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2024-02-06
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2024-02-06
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2021-05-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Brace Align

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 3013002868. Last updated year: 2026. Please use registration number 3013002868 when referencing this establishment in official correspondence.