Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010658

FEI Number

4368

Entity Name

THUASNE DEUTSCHLAND GMBH

City/State/Country

Burgwedel Lower Saxony, DE

Establishment Address

IM STEINKAMP 12, Burgwedel Lower Saxony D-30938, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Thuasne S.A.S. (Owner Number: 10094514)

Owner / Operator Contact Address

120 rue Marius Aufan, Levallois-Perret, FR-NOTA 92300, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bademoden Kollektion Silima, Serena Back Belt Lombastab Sleeq extension Panel Back Belt Lombaskin Pro BOA SI SLEEQ AIR APL SLEEQ Flex TLSO SLEEQ APL SLEEQ MAX Reversa Promaster SLEEQ ADAPT Back Belt Lombastability Boa SLEEQ AIR AP+ Back Belt Lombatech Pro SLEEQ AP Back Belt Lombatech LombaFirst Chiro One BOA w/Chairback SLEEQ AIR AP SLEEQ AP+ BOA Slim Panel XTR BOA LP 8 Mobiderm Standard Mitten Mobiderm Standard Armsleeve Mobiderm Intimate- bra Mobiderm Made to measure Mobiderm Intimate Bra Mobiderm Mobilizing Pads Mobiderm Autofit Sock Mobiderm Autofit Armsleeves Mobiderm - Pad for short, woman version Mobiderm - Pad for short, man version Mobiderm Standard Glove Mobiderm Intimate shorts Lymphatrex Revolution Mobiderm Autofit Socking Protective liner - socks SpryStep Neuro Stat-A-Dyne Knee Rebel 3D Genu Pro Activ Stat-A-Dyne ESP Air Townsend Reliever One Dynamic KAFO Premier SPRYSTEP VECTOR KAFO Sports Series Select Reliever Active Reliever Stat-A-Dyne Wrist Stat-A-Dyne Ankle Genuextrem Premier Trigger ROMX SS Ligastrap Genu Reliever Argicalm Th Sport Patella Reliever Premier Reliever Air Townsend Reliever Compression Calf Sleeves Stat-A-Dyne WHFO RebelPro Rebel Reliever Premier KAFO Bold Full Shell BK Compression Socks Stat-A-Dyne Shoulder GenuStart Dynamic Reliever Reliever Air Lite Rebel Lock ROM-R Genu Ligaflex ROM 4 ExoGuard Action Reliever Stat-A-Dyne Elbow Motocross Series Silistab Genu SpryStep Ligament Reliever Air Full Shell KAFO TS ROM SpryStep OA Rebel The Crusader Genu ProMaster ROM-LX Genu Dynastab Genu Ligaflex ROM Stat-A-Dyne Pronation / Supination PR1 Softforce Reliever UniReliever GenuStart ROM Full Shell ROM 6 SpryStep Footplate SpryStep Carbon Footplate SpryStep Agilik KAFO Bademoden Kollektion Silima, Serena ROM Post-Op Ligaflex Immo Stat-A-Dyne ESP Stat-A-Dyne Pronation / Supination Wrist Dynastab Dual Wrist Ligaflex Manu Silistab Epi Stat-A-Dyne Shoulder Ligaflex Finger Custom Elbow Brace Rhizo Pro Wrist Wrap LigaFlex Pro Plus Ligaflex Boxer Wrist Manu GO G2 Wrist Manu GO Functional Elbow Brace Wrist Ligaflex Immo Ligaflex Classic Open LigaFlex Action LigaFlex Pro Strapping Thumb Support Stat-A-Dyne Wrist Wrist Manurhizo Formit Stat-A-Dyne WHFO Manurhizo Formit Manu ProMaster Manurhizo Junior Epimed Knitted Elbow Sleeve Stat-A-Dyne Elbow Dynastab Dual Elbow Brace Silistab Epi Wrist Ligaflex Rhizo Digiband Stat-A-Dyne Knee Manu GO EpiMed Promaster Wrist Ligaflex Classic Open Wrist Manuimmo Junior Strapping Wrist Band Elbow Brace Epimed Ligaflex Rhizo Manuimmo Junior Epi ProMaster Stat-A-Dyne Ankle Shoulder Immo Classic Shoulder Thuasne Hopital Wrist thumb Brace Rhizo Pro Ligaflex Manu Wrist Manurhizo Junior Ankle Brace Silistab Achillo Ankle Brace Malleoaction Ligacast Anatomic Ligacast Junior Ligacast Air+ Immo Junior ankle brace SpryStep Flex Silistab Achillo SpryStep Plus Achilles Walker Ankle Immobilizer Ligastrap Immo Premier Ankle Brace Malleo Dynastab Select Walker PediWalker Strapping Ankle Brace Ankle Brace Malleo Dynastab Boa Malleo Dynastab Boa Ankle Brace Malleo GO G2 Ankle Immobilizer Ligacast Air+ Malleo ProMaster Ankle Immobilizer Ligacast Anatomic SpryStep Vector SpryStep Paediatric. SpryStep Ligastrap Malleo Premier AFO Ligaflex Immo Malleo Promaster Malleoaction Boa Stabilizing Ankle Brace SpryStep Max EZG8 Ankle Brace Ligastrap Malleo Sprystep One Ligastrap Immo Ankle Brace Malleo Dynastab Malleo GO Knitted Ankle Support XLR8 Ankle Immobilizer Ligacast Junior Biflex Self Adjust Biflex 16+ Biflex 17+ Biplast BiFlexideal Kit BiFlex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOJ	Prosthesis, Breast, External, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2025-12-16
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2025-12-04
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2025-12-04
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2025-12-04
KCZ	Prosthesis, Breast, External, Used With Adhesive	General, Plastic Surgery	Class 1	878.3800	2025-12-16
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2025-12-04
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2025-12-04
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2025-12-04

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Thuasne S.A.S.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011678115	Textile Medicale	Arad, RO
3009591332	THUASNE SAS	SAINT ETIENNE Hauts-de-Seine, FR
3012027699	Thuasne Czech Republic S.R.O	PREDKLASTERI Brno-Venkov, CZ

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010658. Last updated year: 2026. Please use registration number 8010658 when referencing this establishment in official correspondence.