Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010507

FEI Number

3005091242

Entity Name

BAUERFEIND AG

City/State/Country

ZEULENRODA-TRIEBES Thuringia, DE

Establishment Address

Triebeser Strasse 16, ZEULENRODA-TRIEBES Thuringia 07937, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BAUERFEIND AG (Owner Number: 8010507)

Owner / Operator Contact Address

TRIEBESER STRASSE 16, --, ZEULENRODA-TRIEBES, DE-NOTA 07937, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Orthosis, Corrective Shoe, Post-OP-Forefoot/Heel Relief Shoe, SofTec Coxa CoxaTrain LordoLoc ES SecuTec Dorso LumboLoc Forte XT Sports Back Support LumboLoc Forte ES LumboLoc Forte SP b:joynz back support straight b:joynz back support waisted LumboTrain waisted LumboTrain ES LumboTrain LumboTrain straight DorsoTrain LordoLoc SecuTec Lumbo LumboLoc LumboLoc Forte SofTec Dorso LumboLoc ES LumboTrain Lady Spinova Immo SofTec Lumbo Lumbo Plus ViscoSpot, ViscoHeel, ViscoBalance, ViscoPed, ViscoHeel K ViscoPed S VenoTrain glider plus OmoLoc SacroLoc SacroLoc ES GenuTrain P3 OmoTrain GenuTrain S Pro GenuLoc ErgoPad weightflex 2 ErgoPad work:h ErgoPad ball & racket ErgoPad redux heel 2 SecuTec Genu SecuTec Omo ErgoPad ski & skate ErgoPad redux heel AirLoc, SofTec OA, MyoTrain, ValguLoc, Sportfraeseinlagen ManuLoc long Sports Elbow Support Sports Knee Strap MOS Genu, ManuLoc long Plus MalleoLoc, ManuLoc Rhizo long GenuTrain S, Sports Knee Support SofTec Genu, Sports Insoles Run & Walk GloboTec Isoflex Sports Insoles Ski & Skate Sports Elbow Strap Sports Insoles Ball & Racket ManuLoc Rhizo ErgoPad run & walk GenuPoint ManuLoc Rhizo long Plus MalleoLoc L MalleoLoc L3 SecuTec OA ValguLoc II CaligaLoc GenuTrain OA SofTec OA Plus ErgoPad Sensitive GloboTec Polydor professional Ferse GloboTec Junior GloboTec PP-Flex GloboTec Globotherm-Isoflex TRIactive GloboTec Alpha-Cork GloboTec Plastic GloboTec Elastra-Kork ErgoPad redux hallux GloboTec Starflex GloboTec comfort ErgoPad work ErgoPad system:s GloboTec GloboPlast GloboTec Patricia GloboTec Flexible Cork GloboTec Active GloboTec Soft ErgoPad weightflex b:joynz knee support b:joynz wrist support SecuTec Genu Flex RhizoLoc OA Outdoor Compression Elbow Support ManuRhizoLoc OmoTrain S ManuTrain GenuTrain GenuTrain A3 Outdoor Compression Ankle Support Sports Compression Knee Support Outdoor Knee Support Sports Compression Elbow Support EpiPoint Outdoor Compression Knee Support Outdoor Ankle Support ManuLoc Sports Compression Ankle Support Sports Wrist Strap Sports Achilles Support RhizoLoc Sports Ankle Support Dynamic EpiTrain Spinova Osteo Spinova Osteo ES VenoTrain business CerviLoc S CerviLoc Cervical Orthoses pitcher elbow support Sports Elbow Brace b:joynz elbow support Sports Ankle Support b:joynz ankle support AchilloTrain MalleoTrain Plus MalleoTrain MalleoTrain S open heel MalleoTrain S AchilloTrain Pro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2002-02-05
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2013-01-16
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2013-01-16
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2007-12-11
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2025-11-25
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2013-09-16
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2013-01-16
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2001-10-24
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2007-12-11
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2022-06-24
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2007-12-11
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2013-11-04
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2007-12-11

Official Correspondent

Ines Exner

US Agent Details

Michael Cannon Business: Bauerfeind US, Inc. Email: mcannon@bauerfeindusa.com Phone: (703) 5877825

Related Public Records

Same Entity

BAUERFEIND AG

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

Similar Registrations

Registration Number	Establishment Name	Location
3039167356	CADENSE INC	Goleta, CA, US
3017364737	DINH DAT SHOES COMPANY CO LTD	HaiPhong Hai Phong, VN
3045006674	PHUONG LINH TRADING SERVICES AND PRODUCTION COMPANY LIMITED	PuTian Fujian, CN
3030128625	GOLDEN STAR COMPANY LIMITED - BRANCH	Uong Bi Quang Ninh, VN
3029961124	PT. SUKSES ABADI INDONESIA	Kabupaten Nganjuk Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010507. Last updated year: 2026. Please use registration number 8010507 when referencing this establishment in official correspondence.