BANTAM
FDA 510(k) clearance K091242 · decided 2009-07-06
Clearance details
- K-number
- K091242
- Device name
- BANTAM
- Applicant
- Altimate Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-28
- Decision date
- 2009-07-06
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- INO
- Device class
- 2
- Regulation number
- 890.3110
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Elyria, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DALTON LIFT CHAIR (K131909) | Dalton Instrument Corp. | 2014-02-24 |
| EASYSTAND BANTAM MEDIUM (K123834) | Altimate Medical, Inc. | 2013-08-13 |
| FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES (K112944) | Fresenius Medical Care South Asia Pacific Pty , Ltd. | 2011-12-30 |
| COMPACT WHEELCHAIR PLATFORM (K101723) | Design Specific Fletcher | 2010-12-23 |
| LIFT CHAIR, MODEL T3 (K091578) | Pride Mobility Products Corp. | 2009-12-02 |
| MEDICAL TREATMENT CHAIR, T400, T500,T600 (K091727) | Fresenius Medical Care South Asia Pacific Pty , Ltd. | 2009-07-06 |
| STANDARD WHEELCHAIR PLATFORM (K073565) | Design Specific , Ltd. | 2009-02-06 |
| PIVOT ASSIST (K081053) | Pivot Assist, LLC | 2008-10-09 |
| WINCO MODEL POWER SERIES LIFT CHAIR (K080533) | Winco, Inc. | 2008-08-11 |
| CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR (K071793) | Barton Medical Corp. | 2007-08-03 |
| LIFT CHAIR, MODEL C5 (K070950) | Pride Mobility Products Corp. | 2007-04-16 |
| EASYSTAND EVOLV (K062402) | Invacare Corp. | 2006-09-21 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting i recall (Z-0243-2023) | Altimate Medical, Inc. | 2022-11-16 |