510(k) · Cleared
Recalled · 2004TMR48
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pride Health Care, Inc. · INO Chair, Positioning, Electric
Cleared on Sep 8, 1995 after a 59-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 8, 1995
- Review
- 59 days
- Class
- Class II
- Product code
- INO
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK953342 TMR48Pride Health Care, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK070950 Lift Chair, Model C5Pride Mobility Products Corp. · 2007
- Descendant · 2 generations on · 0 of its ownK131909 Dalton Lift ChairDalton Instrument Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK091578 Lift Chair, Model T3Pride Mobility Products Corp. · 2009
- Descendant · cites it directly · 0 of its ownK023521 Easy LifeBerkline Corp. · 2002
Most influential descendants
Showing 4 of 4 · See all- K070950Lift Chair, Model C5Pride Mobility Products Corp. · 2007 · cites it directly2descendants
- K131909Dalton Lift ChairDalton Instrument Corp. · 2014 · 2 generations on0descendants
- K091578Lift Chair, Model T3Pride Mobility Products Corp. · 2009 · 2 generations on0descendants
- K023521Easy LifeBerkline Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953342 | TMR48 | Pride Health Care, Inc. | 1995 | — |
| +1 | K070950 | Lift Chair, Model C5 | Pride Mobility Products Corp. | 2007 | — |
| +2 | K131909 | Dalton Lift Chair | Dalton Instrument Corp. | 2014 | — |
| +2 | K091578 | Lift Chair, Model T3 | Pride Mobility Products Corp. | 2009 | — |
| +1 | K023521 | Easy Life | Berkline Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in INO? 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
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2004 | Not classified | Z-0212-05 | Other | The heating pad on these Lift Chairs may tear at the entry point causing a short and/or overheating, which can damage the chair. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070950 (Pride Mobility Products Corp., 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All INO devicesINO Chair, Positioning, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · INO
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · INO
126in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · INO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · INO
29in 2025
MAUDE reports naming product code INO, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 4 | 126 | 0 | 6 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 1 | — | 0 | 24 |
| 2014 | 1 | — | 0 | 16 |
| 2015 | 0 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 0 | — | 0 | 38 |
| 2019 | 0 | — | 0 | 37 |
| 2020 | 0 | — | 0 | 41 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 0 | — | 1 | 29 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 29 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K953342 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953342: TMR48.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953342
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026