510(k) · Cleared
ClearedHeartway Power Tilt Seating System Power Chair, Model# P16RT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartway Medical Products Co., Ltd. · ITI Wheelchair, Powered
Cleared on Mar 14, 2007 as substantially equivalent to K061693 (Foryou Technology Co., Ltd., 2006) after a 22-day review. Its family tree reaches back 2 generations to 2003. 9 later devices descend from it.
- Decided
- Mar 14, 2007
- Review
- 22 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K022697 (2003). 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK022697 Teh Lin Jupiter Power Chair, Model TL-320Teh Lin Prosthetic & Orthopaedic, Inc. · 2003
- 1 generation backK061693 Foryou Powered Wheelchair, Model FC-100Foryou Technology Co., Ltd. · 2006
- This deviceK070489 Heartway Power Tilt Seating System Power Chair, Model# P16RTHeartway Medical Products Co., Ltd. · 2007
- Descendant · cites it directly · 5 of its ownK071006 Heartway Attendant-Controlled Power Chair, TC1Heartway Medical Products Co., Ltd. · 2007
- Descendant · 2 generations on · 1 of its ownK111095 Breeze Electric Transport Chair Model 1025Electro Kinetic Technologies, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK100327 Heartway Power Chair, P23Heartway Medical Products Co., Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK071005 Heartway Lightweight Power Chair, P15Heartway Medical Products Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK142783 HEARTWAY Electrically Powered Wheelchair P27Heartway Medical Products Co., Ltd. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K071006Heartway Attendant-Controlled Power Chair, TC1Heartway Medical Products Co., Ltd. · 2007 · cites it directly5descendants
- K111095Breeze Electric Transport Chair Model 1025Electro Kinetic Technologies, LLC · 2011 · 2 generations on1descendant
- K100327Heartway Power Chair, P23Heartway Medical Products Co., Ltd. · 2010 · 2 generations on1descendant
- K071005Heartway Lightweight Power Chair, P15Heartway Medical Products Co., Ltd. · 2007 · cites it directly1descendant
- K142783HEARTWAY Electrically Powered Wheelchair P27Heartway Medical Products Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022697 | Teh Lin Jupiter Power Chair, Model TL-320 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2003 | — |
| −1 | K061693 | Foryou Powered Wheelchair, Model FC-100 | Foryou Technology Co., Ltd. | 2006 | — |
| 0 (this device) | K070489 | Heartway Power Tilt Seating System Power Chair, Model# P16RT | Heartway Medical Products Co., Ltd. | 2007 | — |
| +1 | K071006 | Heartway Attendant-Controlled Power Chair, TC1 | Heartway Medical Products Co., Ltd. | 2007 | — |
| +2 | K111095 | Breeze Electric Transport Chair Model 1025 | Electro Kinetic Technologies, LLC | 2011 | — |
| +2 | K100327 | Heartway Power Chair, P23 | Heartway Medical Products Co., Ltd. | 2010 | — |
| +1 | K071005 | Heartway Lightweight Power Chair, P15 | Heartway Medical Products Co., Ltd. | 2007 | — |
| +1 | K142783 | HEARTWAY Electrically Powered Wheelchair P27 | Heartway Medical Products Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 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 ITI? 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 ITI device
- #1 K220747 Power Wheelchair (N5515B)score 40.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K061693 | Foryou Powered Wheelchair, Model FC-100Summary page 1…and their chargers - requirements and test methods) Legally marketed device for substantial equivalence comparison: FORYOU POWERED WHEELCHAIR, FC-100 (K061693) r31… | 2006 |
What descends from it? (9)
3 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)
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 4 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K071006 (Heartway Medical Products Co., Ltd., 2007) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K061693.
How does its category compare?
All ITI devicesITI Wheelchair, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · ITI
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITI
13so far in 2026, the most since 2007
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · ITI
647in 2025
MAUDE reports naming product code ITI, 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 | 18 | 42 | 3 | 123 |
| 2008 | 9 | 49 | 3 | 133 |
| 2009 | 7 | 63 | 1 | 183 |
| 2010 | 6 | 46 | 2 | 157 |
| 2011 | 4 | 101 | 0 | 525 |
| 2012 | 6 | 155 | 1 | 2,919 |
| 2013 | 5 | 177 | 0 | 8,741 |
| 2014 | 5 | 213 | 0 | 7,282 |
| 2015 | 10 | 174 | 0 | 4,685 |
| 2016 | 6 | 173 | 1 | 1,575 |
| 2017 | 4 | 159 | 2 | 301 |
| 2018 | 4 | 117 | 0 | 273 |
| 2019 | 3 | 244 | 0 | 264 |
| 2020 | 6 | 278 | 0 | 205 |
| 2021 | 13 | 209 | 3 | 166 |
| 2022 | 16 | 96 | 0 | 135 |
| 2023 | 8 | 128 | 0 | 223 |
| 2024 | 38 | 125 | 1 | 146 |
| 2025 | 29 | 90 | 3 (2) | 647 |
| 2026 | 36 | 108 | 13 | — |
What is it indicated for?
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070489: Heartway Power Tilt Seating System Power Chair, Model# P16RT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070489
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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