DeviceClearance

TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2— 510(k) K011707

Substantially Equivalent

Merits Medical Industries Co., Ltd.

FDA 510(k) clearance K011707 for TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2, Substantially Equivalent on 2001-08-03. Applicant: Merits Medical Industries Co., Ltd.. Device class: 2.

Clearance details

Applicant
Merits Medical Industries Co., Ltd.
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
Download summary PDFView on FDA.gov ↗

Recent devices under product code INI

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Adverse 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 K011707

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011707.

Data sourced from openFDA. This site is unofficial and independent of the FDA.