Data / Medical devices / Germany / Alber GMBH
Alber GMBH: FDA-registered device maker in ALBSTADT Baden-Wurttemberg, Germany, 8 510(k) clearances
Alber GMBH is registered with the FDA (registration 3004730072) in ALBSTADT Baden-Wurttemberg, Germany. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 24, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004730072
- Address
- VOR DEM Weiben STEIN 14, ALBSTADT Baden-Wurttemberg, Germany, 72461
- Owner or operator
- Invacare Corporation dba Invacare America (1525712)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- April 16, 2001
- Registered through
- 2026
- Brand names listed
- 9805P Hydraulic Lift, AquaSafe Shower Chair, Aquatec J, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP, Aquatec Ocean VIP, Aquatec Orca, Aquatec® R and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Hygiene | ILS | 1 | Contract manufacturer | accessdata.fda.gov |
| Elevator, Wheelchair, Portable | ING | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Contract manufacturer | accessdata.fda.gov |
| Wheelchair, Powered | ITI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 24, 2022 | K221215 | e-motion M25 | ITI | Substantially Equivalent | Alber GmbH | accessdata.fda.gov |
| November 2, 2020 | K192618 | e-Motion M25 | ITI | Substantially Equivalent | Alber GmbH | accessdata.fda.gov |
| May 19, 2020 | K192016 | SMOOV O10 | ITI | Substantially Equivalent | Alber GmbH | accessdata.fda.gov |
| October 5, 2016 | K161241 | e-fix E35/E36 | ITI | Substantially Equivalent | Alber GmbH | accessdata.fda.gov |
| February 23, 2016 | K151717 | twion | ITI | Substantially Equivalent | Alber GmbH | accessdata.fda.gov |
| March 16, 2001 | K003449 | E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS) | ITI | Substantially Equivalent | Ulrich Alber GmbH & Co. | accessdata.fda.gov |
| November 8, 1994 | K943789 | POWER WHEELCHAIR CONVERSION KIT | ITI | Substantially Equivalent for Some Indications | Alber Technologies, Inc. | accessdata.fda.gov |
| August 6, 1992 | K920105 | SCALAMOBIL | ING | Substantially Equivalent | Alber Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Wheelchair, Powered
- All makers of Elevator, Wheelchair, Portable
- All makers of Lift, Patient, Non-Ac-Powered
- All makers of Adaptor, Hygiene
Updated May 24, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.