TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3— 510(k) K011751
Substantially EquivalentMerits Health Products., Inc.
FDA 510(k) clearance K011751 for TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3, Substantially Equivalent on 2001-08-06. Applicant: Merits Health Products., Inc.. Device class: 2.
Clearance details
- Applicant
- Merits Health Products., Inc.
- Product code
- Code INI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3800
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cape Coral, FL, US
Recent devices under product code INI
view allMore clearances from Merits Health Products., Inc.
view allAdverse events under product code INI
product code INI- Injury
- 171
- Other
- 1
- Total
- 172
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 K011751
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 K011751.
Data sourced from openFDA. This site is unofficial and independent of the FDA.