DeviceClearance

WIZARD PEDIATRIC WHEELCHAIR— 510(k) K934560

Substantially Equivalent

Snug Seat, Inc.

FDA 510(k) clearance K934560 for WIZARD PEDIATRIC WHEELCHAIR, Substantially Equivalent on 1994-01-07. Applicant: Snug Seat, Inc.. Device class: 1.

Clearance details

Applicant
Snug Seat, 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
Matthews, NC, US
Download summary PDFView on FDA.gov ↗

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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 →

Recalls naming K934560

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 K934560.

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