510(k) · Cleared
ClearedZip'r PC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Fabtech Wheelchair (Shanghai) Co., Ltd. · ITI Wheelchair, Powered
Cleared on Sep 21, 2007 as substantially equivalent to K062888 (Emg Technology Co., Ltd., 2006) after a 42-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- Sep 21, 2007
- Review
- 42 days
- Class
- Class II
- Product code
- ITI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K023148 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK023148 Epw Powered Wheelchair, GP-201Emg Technology Co., Ltd. · 2003
- 1 generation backK062888 Middle Wheel Drive Power Chair, CWD01Emg Technology Co., Ltd. · 2006
- This deviceK072224 Zip'r PCGlobal Fabtech Wheelchair (Shanghai) Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK102355 Zip'r Mantis Powered WheelchairGlobal Fabtech Wheelchair (Shanghai) Co., Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K102355Zip'r Mantis Powered WheelchairGlobal Fabtech Wheelchair (Shanghai) Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023148 | Epw Powered Wheelchair, GP-201 | Emg Technology Co., Ltd. | 2003 | — |
| −1 | K062888 | Middle Wheel Drive Power Chair, CWD01 | Emg Technology Co., Ltd. | 2006 | — |
| 0 (this device) | K072224 | Zip'r PC | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 2007 | — |
| +1 | K102355 | Zip'r Mantis Powered Wheelchair | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 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 |
|---|---|---|---|
| * | K062888 | Middle Wheel Drive Power Chair, CWD01Summary page 1…wheelchair Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3860 Product Code: ITI Classification: Class II Predicate devices CWD01 (K062888) / EMG Technology Co. Ltd. Intend use of device Zip'r PC powered wheelchair is intended for an indoor/outdoor power wheelchair… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102355 | Zip'r Mantis Powered Wheelchair | 2010 | 0 |
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 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102355 (Global Fabtech Wheelchair (Shanghai) Co., Ltd., 2010) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K062888.
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 Zip'r PC powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
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/K072224 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072224: Zip'r PC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072224
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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