Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2951574

FEI Number

1000523125

Entity Name

Thuasne, LLC

City/State/Country

BAKERSFIELD, CA, US

Establishment Address

4615 SHEPARD ST., BAKERSFIELD, CA 93313, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Thuasne, LLC (Owner Number: 9011981)

Owner / Operator Contact Address

120 Osage Ave, Kansas City, KS 66105, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kit BiFlex Biflex 17+ BiFlexideal Biplast Biflex 16+ Biflex Self Adjust Ankle Brace Malleo Dynastab Boa Ankle Brace Malleo GO G2 Ankle Brace Silistab Achillo Ankle Brace Malleo Dynastab Ankle Immobilizer Ligacast Junior Ankle Immobilizer Ligacast Anatomic Ankle Brace Ligastrap Malleo Ankle Immobilizer Ligastrap Immo Ankle Brace Malleoaction Ankle Immobilizer Ligacast Air+ XLR8 Ligastrap Malleo Malleo Dynastab SpryStep Max Malleoaction Achilles Walker Silistab Achillo Malleo GO Premier AFO SpryStep SpryStep Plus Ligastrap Immo Ligacast Anatomic Malleo Dynastab Boa Ligaflex Immo Ligacast Air+ Strapping Ankle Brace Ligacast Junior PediWalker Premier Ankle Brace Boa Stabilizing Ankle Brace EZG8 SpryStep Flex SpryStep Paediatric. Knitted Ankle Support Malleo ProMaster Malleo Promaster Immo Junior ankle brace Sprystep One Select Walker SLEEQ APL SLEEQ AIR AP+ BOA w/Chairback Lombastab BOA Slim Panel XTR Lombaskin Pro SLEEQ AP+ SLEEQ AP Lombatech Pro SLEEQ AIR AP Lombamum SLEEQ AIR APL BOA SI BOA LP 8 Lombatech Reversa ProMaster SLEEQ ADAPT SLEEQ ADAPT 639 Collar Thuasne Hospital C1 Collar Ortel C2+ Collar Ortel C1 Junior Collar C4 Vario Collar C4 Eclipse EXT Cervical Collar Ortel C42 Vario Collar Ortel C2 Plus Eclipse Cervical Collar Collar Thuasne C1 ORTEL T-NECK CTO w/ full Replacement Pad Kit Ortel T-Neck Cervical Thoracic Orthosis (CTO) ORTEL T-NECK CTO Full Pad and Strap Replacement KIT Air Townsend Dynamic Reliever Genu Ligaflex Genu Ligaflex ROM Full Shell KAFO Softforce Reliever ROM-R Bold Premier Trigger ROMX SS RebelPro Premier KAFO TS ROM Action Reliever Silistab Genu Air Townsend Reliever Rebel Lock PR1 Premier Rebel Reliever One ROM 6 Rebel Reliever Premier Reliever Active Reliever Sports Series Genuextrem Reliever Genu Pro Activ ROM 4 Full Shell Patella Reliever Ligastrap Genu Motocross Series Genu Dynastab Reliever Air Reliever Air Lite Dynamic KAFO Full Shell BK Genu ProMaster Compression Socks ExoGuard Compression Calf Sleeves GenuStart ROM-LX SPRYSTEP VECTOR KAFO Rebel 3D UniReliever SpryStep Neuro Stat-A-Dyne Knee Argicalm Th Sport Stat-A-Dyne WHFO SpryStep OA SpryStep Carbon Footplate Select Reliever GenuStart ROM Stat-A-Dyne ESP Stat-A-Dyne Elbow Stat-A-Dyne Wrist SpryStep Footplate SpryStep Agilik KAFO SpryStep Ligament Stat-A-Dyne Ankle Stat-A-Dyne Pronation / Supination Stat-A-Dyne Shoulder The Crusader Back Belt Dorso Rigid T35 SLEEQ Flex BOA Duel TLSO Osteomed Acute SLEEQ Max SLEEQ + Flex SLEEQ Adapt 456 Dorso Rigid Sleeq Extension Panel Dorso Rigid 35 Townsed Design Inc. Night Splint NOX Splint Townsend Shoulder Sling Immo Classic Elite Shoulder Sling AeroSling Shoulder Immobilization Vest Arm sling TD Shoulder Sling Clavicular Ligaflex Clavicular Ligaflex Junior Mobiderm Autofit Socking Mobiderm Standard Mitten Mobiderm Standard Glove Mobiderm Autofit Sock Mobiderm Mobilizing Pads Mobiderm Autofit Armsleeves Mobiderm Standard Armsleeve Mobiderm Intimate Bra Mobiderm Made to measure Mobiderm Intimate shorts Lymphatrex Revolution Mobiderm Intimate- bra Mobiderm - Pad for short, man version Mobiderm - Pad for short, woman version Vector 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2019-12-04
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2015-04-16
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2018-02-19
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	1994-11-28
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	1994-11-28
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2017-04-14
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2018-02-19
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	2018-02-19
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2018-02-19
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2015-04-16
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2019-12-05
JFA	Exerciser, Finger, Powered	Physical Medicine	Class 1	890.5410	2024-01-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Thuasne, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1064876	Thuasne, LLC	Hamlet, NC, US
1922710	Thuasne, LLC	KANSAS CITY, KS, US
3025770454	Thuasne, LLC	Chihuahua, MX

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 2951574. Last updated year: 2026. Please use registration number 2951574 when referencing this establishment in official correspondence.