510(k) · Cleared
ClearedBalder Finesse and Junior Powered Wheelchairs (with Stand-UP Option)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etac Sverige AB · IPL Wheelchair, Standup
Cleared on Dec 21, 2007 as substantially equivalent to K051387 (Levo AG, 2005) and 1 other predicate after a 108-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 21, 2007
- Review
- 108 days
- Class
- Class II
- Product code
- IPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K940972 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940972 | Model MCC - Mkiv Micro Computer Controls | Invacare Corp. | 1994 | — |
| −1 | K970094 | Model DX Micro Computer Control | Invacare Respiratory Corp. | 1997 | — |
| 0 (this device) | K072475 | Balder Finesse and Junior Powered Wheelchairs (with Stand-UP Option) | Etac Sverige AB | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
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 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 K203761 ParaMotionscore 3.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051387 | Levo Comfort IISummary page 3…Finesse and Balder Junior stand-up powered wheelchairs by Etac and the predicate device, the LEVO Comfort II (K051387), do not raise any questions regarding their safety and effectiveness. The Balder Finess… | 2005 |
| * | K970094 | Model DX Micro Computer ControlSummary page 2…Dynamic Controls, a division of Invacare Corporation, and was previously cleared by the FDA on May 12, 1997 (see K970094). Intended Use: The Balder Finesse and Balder Junior stand-up powered wheelchairs by E… | 1997 |
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 13 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 3 other devices also cite its predicate K051387.
How does its category compare?
All IPL devicesIPL Wheelchair, Standup: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IPL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPL
105in 2019
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
MAUDE reports naming product code IPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 63 | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 3 | 105 | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Balder Finesse and Balder Junior stand-up powered wheelchairs by Etac are indoor/outdoor battery operated multifunctional wheelchairs. The intended use of these powered wheelchairs is to provide mobility to persons that have the capability of operating a powered wheelchair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072475 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072475: Balder Finesse and Junior Powered Wheelchairs (with Stand-UP Option).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072475
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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