V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
FDA 510(k) clearance K090805 · decided 2009-04-03
Clearance details
- K-number
- K090805
- Device name
- V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
- Applicant
- Pride Mobility Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-25
- Decision date
- 2009-04-03
- Days to decision
- 9 days
- Clearance type
- Special
- Product code
- INI
- Device class
- 2
- Regulation number
- 890.3800
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Exeter, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.