510(k) K861943
- Device
- PCI CUSTOM DESIGN SERIES
- Applicant
- POSTON & COLE INTL.
- 510(k) number
- K861943
- Product code
- IQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-05-30
- Date received
- 1986-05-20
- Regulation
- 890.3880
- Classification name
- Wheelchair, Special Grade
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUDY BAHR
- Address
- 2550 Ninth St., Suite 111 Berkeley CA US 94710 94710
FDA Registration Numbers#
- 3005442882
- 3009560097
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IQC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251570 | Hippocampe Marathon and Trail | Vipamat Sarl | 2025-06-23 |
| K120302 | MECHANICAL WHEELCHAIR | Novaf Andalucia 2007, SL | 2012-07-06 |
| K082857 | RENEGADE WHEELCHAIR | Alpha One | 2009-01-06 |
| K051709 | HIPPOCAMPE WHEELCHAIR | Vipamat Technologie | 2005-08-15 |
| K895384 | CALIFORNIA COMFORT FOUR WHEEL | Jubilee Scooters, Inc. | 1989-09-18 |
| K843213 | QUALINE WHEELCHAIR PRODUCTS | Contemporary Health Sys | 1984-08-24 |
| K842719 | STANDARD WHEELCHAIR | Greene International Corp. | 1984-07-25 |
| K840234 | POIRIER VARIABLE WHEELCHAIR | Poirier S.A. | 1984-02-27 |
| K840625 | UNION WHEELCHAIR | Poirier S.A. | 1984-02-27 |
| K840627 | AMPUTEE WHEELCHAIR | Poirier S.A. | 1984-02-27 |
| K840628 | LARGE FRONT WHEELS WHEELCHAIR | Poirier S.A. | 1984-02-27 |
| K840630 | POIRIER REGLADE WHEELCHAIR | Poirier S.A. | 1984-02-27 |
| K840631 | ARNAS WHEELCHAIR | Poirier S.A. | 1984-02-27 |
| K840632 | HEMIPLEGIC WHEELCHAIR | Poirier S.A. | 1984-02-27 |
| K840634 | OLYMPIC & BASKET WHEELCHAIRS | Poirier S.A. | 1984-02-27 |
Legacy Summary#
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FDA Review#
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