CALIFORNIA COMFORT FOUR WHEEL
FDA 510(k) clearance K895384 · decided 1989-09-18
Clearance details
- K-number
- K895384
- Device name
- CALIFORNIA COMFORT FOUR WHEEL
- Applicant
- Jubilee Scooters, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-30
- Decision date
- 1989-09-18
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- IQC
- Device class
- 2
- Regulation number
- 890.3880
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Foster City, CA, 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 |
|---|---|---|
| Hippocampe Marathon and Trail (K251570) | Vipamat Sarl | 2025-06-23 |
| MECHANICAL WHEELCHAIR (K120302) | Novaf Andalucia 2007, SL | 2012-07-06 |
| RENEGADE WHEELCHAIR (K082857) | Alpha One | 2009-01-06 |
| HIPPOCAMPE WHEELCHAIR (K051709) | Vipamat Technologie | 2005-08-15 |
| PCI CUSTOM DESIGN SERIES (K861943) | Poston & Cole Intl. | 1986-05-30 |
| QUALINE WHEELCHAIR PRODUCTS (K843213) | Contemporary Health Sys | 1984-08-24 |
| STANDARD WHEELCHAIR (K842719) | Greene International Corp. | 1984-07-25 |
| POIRIER VARIABLE WHEELCHAIR (K840234) | Poirier S.A. | 1984-02-27 |
| AMPUTEE WHEELCHAIR (K840627) | Poirier S.A. | 1984-02-27 |
| ARNAS WHEELCHAIR (K840631) | Poirier S.A. | 1984-02-27 |
| UNION WHEELCHAIR (K840625) | Poirier S.A. | 1984-02-27 |
| HEMIPLEGIC WHEELCHAIR (K840632) | Poirier S.A. | 1984-02-27 |
Recalls involving this device
No recalls on record reference this clearance.