FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50— 510(k) K063736
Substantially EquivalentPdg Product Design Group, Inc.
FDA 510(k) clearance K063736 for FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50, Substantially Equivalent on 2007-01-17. Applicant: Pdg Product Design Group, Inc.. Device class: 1.
Clearance details
- Applicant
- Pdg Product Design Group, Inc.
- 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
- Traditional
- Location
- Cleveland, OH, US
Recent devices under product code IOR
view allMore clearances from Pdg Product Design Group, Inc.
view allAdverse 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 →
Recalls naming K063736
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063736.
Data sourced from openFDA. This site is unofficial and independent of the FDA.