510(k) Report

510(k) · Cleared

Cleared

Nissin Pediatric Series Wheelchair

K063521510(k) TraditionalCleared Feb 5, 200775-day reviewClass I21 CFR 890.3100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nissin Medical, Inc. · INM Chair, With Casters

Cleared on Feb 5, 2007 as substantially equivalent to K032402 (Convaid Products, Inc., 2003) after a 75-day review. Its family tree reaches back 2 generations to 1995.

Decided
Feb 5, 2007
Review
75 days
Class
Class I
Product code
INM
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K952641 (1995). No later device cites it as a predicate yet.

K952641 · Quickie TSR · Sunrise Medical, Inc. · 1995K032402 · Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T, · Convaid Products, Inc. · 20031996199820002002200420062008
K032402 · Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T, · Convaid Products, Inc. · 2003K952641 · Quickie TSR · Sunrise Medical, Inc. · 19950
  1. Root · 2 generations backK952641 Quickie TSRSunrise Medical, Inc. · 1995
  2. 1 generation backK032402 Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T…Convaid Products, Inc. · 2003
  3. This deviceK063521 Nissin Pediatric Series WheelchairNissin Medical, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K952641Quickie TSRSunrise Medical, Inc.1995—
−1K032402Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,Convaid Products, Inc.2003—
0 (this device)K063521Nissin Pediatric Series WheelchairNissin Medical, Inc.2007—
FIG. 1 — Lineage of K063521, 1995–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in INM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K032402Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,
Summary page 1
…fication: 21 CFIR Part 890.3850 Mechanical Wheelchair Device Product Code: IOR Substantially Equivalent Device: Rodeo Models by Convaid (K032402). Device Description: The NISSIN Pediatric Series Wheelchair consists of typical components found on most wheelchairs, such as…
Convaid Products, Inc.2003—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All INM devices

INM Chair, With Casters: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · INM

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · INM

Too few INM 510(k)s in any year since 2007 to give a median.

Recalls per year · INM

1in 2021

2010: 12011: 32012: 112017: 12021: 1
2007high 11 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · INM

15in 2025

2007: 122008: 132009: 122010: 102011: 492012: 1752013: 4632014: 6772015: 152016: 182017: 82018: 112019: 132020: 92021: 222022: 112023: 112024: 82025: 15
2007high 677 (2014) · low 8 (2017)2025

MAUDE reports naming product code INM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—012
20080—013
20090—012
20100—110
20110—349
20120—11175
20130—0463
20140—0677
20150—015
20160—018
20170—18
20180—011
20190—013
20200—09
20210—122
20220—011
20230—011
20240—08
20250—015
20260—0—

What is it indicated for?

The NISSIN Pediatric Series Wheelchair is intended to be used to empower persons physically challenged to a sitting position by providing a means of mobility.

Indications for use as stated in the FDA summary.

Recent decisions in INM

The INM category page

  • K941738Stryker 5050 StrechairStryker Medical · 1994
  • K941569Caremor ClinerWinco, Inc. · 1994
  • K933000Reclining Geri Chairs W/Casters & Lap TrayWinco, Inc. · 1993
  • K926028BenchesTheradapt Products, Inc. · 1993
  • K926054Eld-Arondak ChairAl'S Woodcraft, Inc. · 1993

https://510kreport.com/device/K063521 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063521: Nissin Pediatric Series Wheelchair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063521

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026