Cleared Traditional

K063521 - NISSIN PEDIATRIC SERIES WHEELCHAIR

K063521 is an FDA 510(k) clearance for NISSIN PEDIATRIC SERIES WHEELCHAIR, manufactured by Nissin Medical, Inc.. The device is a Class 1 Physical Medicine device with product code INM cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K063521 · Nissin Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
75d
Days
Class 1
Risk

K063521 is an FDA 510(k) clearance for the NISSIN PEDIATRIC SERIES WHEELCHAIR. Classified as Chair, With Casters (product code INM), Class I - General Controls.

Submitted by Nissin Medical, Inc. (Torrance, US). The FDA issued a Cleared decision on February 5, 2007 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3100 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063521

510(k) Number K063521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2006
Decision Date February 05, 2007
Days to Decision 75 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 116d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

INM Device Classification - Class 1, General Controls

Product Code INM Chair, With Casters
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - INM Chair, With Casters

All 32
Devices cleared under the same product code (INM) and FDA review panel - the closest regulatory comparables to K063521.
STRYKER 5050 STRECHAIR
K941738 · Stryker Medical · May 1994
CAREMOR CLINER
K941569 · Winco, Inc. · Apr 1994
RECLINING GERI CHAIRS W/CASTERS & LAP TRAY
K933000 · Winco, Inc. · Sep 1993
BENCHES
K926028 · Theradapt Products, Inc. · Mar 1993
CHAIRS
K926025 · Theradapt Products, Inc. · Mar 1993
ELD-ARONDAK CHAIR
K926053 · Alert Care, Inc. · Mar 1993
K063521 · NISSIN PEDIATRIC SERIES WHEELCHAIR
Download PDF FDA Summary Nissin Medical, Inc.