510(k) · Cleared
ClearedStannah Power Chair, Model 201
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stannah Power Chairs, Ltd. · IPL Wheelchair, Standup
Cleared on Apr 4, 2001 as substantially equivalent to K945936 (Pride Health Care, Inc., 1996) after a 488-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 4, 2001
- Review
- 488 days
- Class
- Class II
- Product code
- IPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945936 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK945936 JAZZYPride Health Care, Inc. · 1996 · Recalled
- This deviceK994083 Stannah Power Chair, Model 201Stannah Power Chairs, Ltd. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945936 | JAZZY | Pride Health Care, Inc. | 1996 | 1 |
| 0 (this device) | K994083 | Stannah Power Chair, Model 201 | Stannah Power Chairs, Ltd. | 2001 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K945936 | JAZZYSummary page 1…SD England " Common or Usual Name Powered Wheelchair Classification Name Wheelchair, Powered Predicative Devices Pride Health Care "Jazzy" Powered Wheelchair (510(k) # K 945936 date 05/28/94) 1.1.0 KQ@HOYB_ 2o > Intended Use The Stannah power Chair is intended as a device to provide per… | 1996 |
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?
- Its one ancestor has a recall.
- 7 other devices also cite its predicate K945936.
How does its category compare?
All IPL devicesIPL Wheelchair, Standup: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Stannah Power Chair is intended as a device to provide personal transport for a person with walking difficulties. It is specifically designed for indoor use in a domestic type environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994083 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994083: Stannah Power Chair, Model 201.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994083
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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