510(k) K973373
- Device
- Prevent I
- Applicant
- THE BUZZZ CORP.
- 510(k) number
- K973373
- Product code
- INO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-26
- Date received
- 1997-09-08
- Regulation
- 890.3110
- Classification name
- Chair, Positioning, Electric
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEN CASEY
- Address
- 213 E. Luzerne Ave. Larksville PA US 18704 18704
FDA Registration Numbers#
- 3030514731
- 3004132709
- 2183634
- 3038381831
- 3031751374
- 3017580820
- 2531465
- 3006160539
- 3010072581
- 3031696840
- 2531618
- 3006791235
- 3023852281
- 3007632745
- 3031595780
- 3007608806
- 1651499
- 3014498763
- 3005505368
- 3015809017
- 3038276143
- 3019865493
- 3044470904
- 3012425482
- 3016678950
- 3022947232
- 3000335752
- 3008457024
- 1417592
- 3008457027
- 3015972776
- 3015286905
- 3043729621
- 3012008861
- 3016712364
- 3003755213
- 3013208489
- 3016462378
- 3014539793
- 3011191255
- 3011537487
- 2523955
- 3034629632
- 3011574775
- 3038304894
- 3030091564
- 3003636180
- 1831750
- 3003908754
- 3042255028
- 3015494742
Source Documents#
510(k) summary PDF not indicated by FDA
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|---|---|---|---|
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| K101723 | COMPACT WHEELCHAIR PLATFORM | Design Specific Fletcher | 2010-12-23 |
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| K091242 | BANTAM | Altimate Medical, Inc. | 2009-07-06 |
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| K081053 | PIVOT ASSIST | Pivot Assist, LLC | 2008-10-09 |
| K080533 | WINCO MODEL POWER SERIES LIFT CHAIR | Winco, Inc. | 2008-08-11 |
| K071793 | CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR | Barton Medical Corp. | 2007-08-03 |
| K070950 | LIFT CHAIR, MODEL C5 | Pride Mobility Products Corp. | 2007-04-16 |
| K062402 | EASYSTAND EVOLV | Invacare Corp. | 2006-09-21 |
| K060212 | MERITS MODEL E SERIES LIFT CHAIRS | Merits Health Products Co., Ltd. | 2006-03-07 |
| K031045 | AEROLET TOILET LIFT, MODEL AER-01 | Economic Holland B.V. | 2003-07-10 |