Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005083016

FEI Number

3005083016

Entity Name

SPORLASTIC GMBH & Co.KG

City/State/Country

NURTINGEN Baden-Wurttemberg, DE

Establishment Address

Weberstr. 1, NURTINGEN Baden-Wurttemberg 72622, DE

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SPORLASTIC GMBH (Owner Number: 9033265)

Owner / Operator Contact Address

WEBERSTRASSE 1, --, NUERTINGEN, DE-BW D-72622, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COXA-HiT FOOTCARE ELIO FOOTCARE GEA sporlastic OMO-HiT ARTHROFIX NEURO-LUX II RHIZO-RING STUTTGART SHOULDER-ARM SUPPORT RHIZO-HiT SWEDE-O-UNIVERSAL X8 RHIZOSPLINT ELASTIC THUMB SUPPORT CALCALASTIC CALCALASTIC LONG THUMB SADDLE JOINT BRACE SWEDE-O-UNIVERSAL OMO-LUX RHIZO-HiT CLASSIC RHIZO-RING SOFT GENU-TEX MORBUS SCHLATTER KNEE SUPPORT GENU-HiT RS KNEO PATELLADYN GENU-HiT + MENISKUS KNEE SUPPORT ROM KNEE BRACE SUPER-GENUPLUS GENU-HiT WING GENU-HiT + COMFORT GENU-HiT GENUSTABIL V-FORCE GENU-HiT GS KASSELER PATELLAR TENDON BANDAGE KASSELER PATELLAR TENDON BANDAGE CLASSIC KASSELER PATELLAR TENDON BANDAGE AKTIV MANUDYN MANU-CAST DORSAL MOBILAS II MANU-HiT DIGITUS MANUDYN POLLEX MANU-HiT CLASSIC MANU-HiT POLLEX CLASSIC MANU-HiT CARPAL NEURO-RESTRICT MANU-HiT MANU-X MANU-HiT POLLEX MANU-CAST NEURODYN COMFORT NEURODYN SPASTIC NEURODYN DYNAM-X ACTIVE NEURODYN CLASSIC NEURODYN DYNAM-X FLEX SP ELBOW-HAND-BRACE OLECRANON-BANDAGE ROM ELBOW BRACE EPIDYN AKTIV EPI-HiT CLASSIC CUBIDYN EPI-HiT EPIDYN EPIDYN STABIL RIB BELT FOR MEN RIB BELT FOR WOMEN

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2018-07-27
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2018-07-27
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2008-01-02
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2018-07-27
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2018-07-26
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2010-02-24
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2018-07-27
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2018-07-24
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2018-07-27

Official Correspondent

WALTER MICHAEL LEUTHE

US Agent Details

Andy Opliger Business: United Ortho, INC. Email: andyo@united-ortho.com Phone: (800) 2278748

Related Public Records

Same Entity

SPORLASTIC GMBH

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3011528799	OPTEC USA, INC	SAN PEDRO DE MACORIS, DO
8010507	BAUERFEIND AG	ZEULENRODA-TRIEBES Thuringia, DE
9614671	NIPPON SIGMAX CO., LTD.	SHINJUKU-KU Tokyo, JP
3010182295	ZHANGPU ORTHOLIFE REHABILITATION CO., LTD	Zhangzhou Fujian, CN
9616933	I-MING SANITARY MATERIALS CO., LTD.	Changhua, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005083016. Last updated year: 2026. Please use registration number 3005083016 when referencing this establishment in official correspondence.