510(k) K130864
- Device
- C-MAX+ (PLUS)
- Applicant
- AAT ALBER ANTRIEBSTECHNIK GMBH
- 510(k) number
- K130864
- Product code
- ILK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-02-06
- Date received
- 2013-03-28
- Regulation
- 890.5150
- Classification name
- Transport, Patient, Powered
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEFANIE D BANKSTON
- Address
- 2611 Shark Cir. Texas City TX US 77591 77591
FDA Registration Numbers#
- 3005753836
- 3008729900
- 1831750
- 3008791629
- 9615370
Source Documents#
Other 510(k) Records For Product Code ILK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240843 | GENESIS (MS-P02-GEN) | Climbing Steps, Inc. | 2024-10-07 |
| K222818 | Xpedition ™ Powered Stair Chair (625700000000) | Stryker Medical | 2023-01-24 |
| K121560 | LEVANT, HOMEGLIDE | Thyssenkrupp Accessibility B.V. | 2012-11-01 |
| K121561 | FLOW2, SWING | Thyssenkrupp Accessibility B.V. | 2012-10-26 |
| K113308 | BRUNO ELAN STAIRWAY ELEVATOR | Bruno Independent Living Aids, Inc. | 2012-02-01 |
| K111858 | LIFTKAR PT | Sano Transportgeraete GmbH | 2011-11-04 |
| K103122 | C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG | Aat Alber Antriebstechnik GmbH | 2010-12-30 |
| K093946 | HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 | Hoveround Corp. | 2010-03-22 |
| K091858 | PINNACLE STAIR WAY LIFT | Summit Harmar, LLC | 2009-07-01 |
| K073110 | MERITS E600 SERIES STAIR LIFT | Merits Health Products Co., Ltd. | 2008-02-06 |
| K033829 | BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 | Bruno Independent Living Aids, Inc. | 2003-12-29 |
| K033752 | BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 | Bruno Independent Living Aids, Inc. | 2003-12-12 |
| K033438 | BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 | Bruno Independent Living Aids, Inc. | 2003-11-20 |
| K032880 | SUMMIT STAIRWAY LIFT | Summit Lifts, Inc. | 2003-11-10 |
| K023852 | STAIRFRIEND CURVED STAIRWAY CHAIRLIFT | Services Industriels Savaria, Inc. | 2003-03-04 |
Legacy Summary#
summary
FDA Review#
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