KIDS ROCK 3 CHAIR— 510(k) K111739
Substantially EquivalentPride Mobility Products Corp.
FDA 510(k) clearance K111739 for KIDS ROCK 3 CHAIR, Substantially Equivalent on 2011-08-12. Applicant: Pride Mobility Products Corp.. Device class: 1.
Clearance details
- Applicant
- Pride Mobility Products Corp.
- Product code
- Code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Exeter, PA, US
Recent devices under product code IOR
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view all- K091578 — LIFT CHAIR, MODEL T3
- K092961 — JAZZY FRONTIE
- K092088 — VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713
- K091113 — MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL SC940V
- K090805 — V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710
Adverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.