510(k) Report

510(k) · Cleared

Cleared

Rabbit Mobile Standing Frame

K030882510(k) TraditionalCleared Apr 4, 200315-day reviewClass II21 CFR 890.3900

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

R82 A/S · IPL Wheelchair, Standup

Cleared on Apr 4, 2003 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Apr 4, 2003
Review
15 days
Class
Class II
Product code
IPL
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K030882Source: FDA 510(k) database · 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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

Top candidate predicates for a new IPL device

  1. #1 K203761 ParaMotionscore 3.3 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

How does its category compare?

All IPL devices

IPL Wheelchair, Standup: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IPL

1in 2025

2007: 32008: 12009: 12010: 22013: 12015: 12018: 22019: 32020: 22022: 22025: 1
2007high 3 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPL

105in 2019

2007: 63 days median2019: 105 days median
2007high 105 (2019) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IPL

No recall names IPL since 2007.

Adverse event reports per year · IPL

5in 2025

2008: 12010: 12013: 32014: 12015: 32018: 12019: 12021: 42022: 32023: 92024: 62025: 5
2007high 9 (2023) · low 0 (2007)2025

MAUDE reports naming product code IPL, 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
200736300
20081—01
20091—00
20102—01
20110—00
20120—00
20131—03
20140—01
20151—03
20160—00
20170—00
20182—01
2019310501
20202—00
20210—04
20222—03
20230—09
20240—06
20251—05
20260—0—

What is it indicated for?

The Rabbit Mobile Standing Frame is a mobile transport device for a child who needs to transition from prone to upright standing, and requires anterior support from feet to sternum during incremental weight bearing from prone to upright standing. The Rabbit is utilized by a child who displays good head, neck, and upper body control. and is functionally able to move the stander under their own volition, but requires support and alignment in weight bearing.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K030882: Rabbit Mobile Standing Frame.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030882

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