NISSIN PEDIATRIC SERIES WHEELCHAIR— 510(k) K063521

Name: FDA 510(k) clearance K063521
Creator: U.S. Food and Drug Administration
Published: 2007-02-05

Substantially Equivalent

Nissin Medical, Inc.

FDA 510(k) clearance K063521 for NISSIN PEDIATRIC SERIES WHEELCHAIR, Substantially Equivalent on 2007-02-05. Applicant: Nissin Medical, Inc.. Device class: 1.

Clearance details

Applicant: Nissin Medical, Inc.
Product code: Code INM
Device class: Class 1
Regulation: 21 CFR 890.3100
Advisory panel: Physical Medicine
Date received: 2006-11-22
Decision date: 2007-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code INM

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K941738 — STRYKER 5050 STRECHAIR1994-05-06
K941569 — CAREMOR CLINER1994-04-26
K933000 — RECLINING GERI CHAIRS W/CASTERS & LAP TRAY1993-09-30
K926028 — BENCHES1993-03-24
K926025 — CHAIRS1993-03-22

Adverse events under product code INM

product code INM

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.