Invacare GmbH

FDA Device Registration & Listing · Isny Baden-Wurttemberg, DE · Registration 3007231105

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007231105
FEI Number
3007231105
Entity Name
Invacare GmbH
City/State/Country
Isny Baden-Wurttemberg, DE
Establishment Address
Am Achener Hof 8, Isny Baden-Wurttemberg 88316, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Invacare Corporation dba Invacare America (Owner Number: 1525712)
Owner / Operator Contact Address
One Invacare Way, Elyria, OH 44035, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Daily Activity Assist Device Trans Disk INVACARE GRAY SPLASH SHIELD Invacare Vinyl Padded Shower Chair Drop Arm Stationary Commode Invacare Folding Shower Chair with Back Aquatec Ocean Dual-VIP Invacare Shower Chair Aquatec Ocean E-VIP Aquatec Ocean VIP Ocean Ergo VA Ocean VIP Ergo Dir. Lock VA Overbed Table Ocean Ergo XL Dir. Lock Mariner Series Ocean Dual-VIP Ergo Dir. Lock VA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ILS Adaptor, Hygiene Physical Medicine Class 1 890.5050 2005-02-08

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

Invacare Corporation dba Invacare America
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008370501 Invacare Portugal, Lda Leca do Balio Porto, PT
3007582653 Invacare UK Ltd. Bridgend, GB
2081283 FREEDOM DESIGNS, INC. SIMI VALLEY, CA, US
3004730072 ALBER GMBH ALBSTADT Baden-Wurttemberg, DE
1531186 INVACARE CORP. DBA INVACARE AMERICA ELYRIA, OH, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K830425 Maddak, Inc. TOILET SEAT RAISED 1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007231105. Last updated year: 2026. Please use registration number 3007231105 when referencing this establishment in official correspondence.
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