Zippie TS SE
The Zippie® TS is the original, premier pediatric tilt-in-space wheelchair. Available with either a folding or rigid frame, built-in growth, and compatible with many seating and positioning…
The Zippie® TS is the original, premier pediatric tilt-in-space wheelchair. Available with either a folding or rigid frame, built-in growth, and compatible with many seating and positioning solutions, the TS has the widest variety of options in the tilt-in-space market.
46manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
9recalls on this code
Who Else Makes It
Concentrated in Jiangsu (19), Guangdong (14), Zhejiang (4). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 32 |
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 31 |
| Trolli King (Holding) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 23 |
| Jiangsu Assure Medical Equipment Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 18 |
| Foshan Shunkangda Medical Tech Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 16 |
| Raise Medical Industries, Inc. | Foshan | Guangdong | Contract manufacturer | 16 |
| Jiaxing Xinyi Medical Instrument Co., Ltd. | Jiashan | Zhejiang | Contract manufacturer | 12 |
| Zhenjiang Kawaza Medical Products Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Pinkang Medical Technology Co Ltd | Danyang | Jiangsu | Contract manufacturer | 8 |
| Fujian Pacific Medical Manufacturing Co., Ltd. | Yunxiao County | Fujian | Contract manufacturer | 6 |
| Xiamen Taft Medical Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 6 |
| Imami Toys Hebei Co., Ltd. | Handan | Hebei | Contract manufacturer | 2 |
Showing 12 of 46. All 46 manufacturers in China registered for Wheelchair, Mechanical
Record
| Listed by | Sunrise Medical (US) LLC, United States |
|---|---|
| FDA product code | IOR |
| Device type | Wheelchair, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3850 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2023-11-14 |
| Record revised | 2025-05-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TS SE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drivemedical | Drive DeVilbiss Healthcare | 329 |
| Drive | Drive DeVilbiss Healthcare | 303 |
| Gendron | GF Health Products, Inc | 158 |
| Everest & Jennings | GF Health Products, Inc | 106 |
| Probasics | Drive DeVilbiss Healthcare | 75 |
| Evermed | Xiamen Taft Medical Co., Ltd. | 48 |
| Convaid | Convaid Products LLC | 46 |
| Karman Healthcare | Karman Healthcare Inc. | 41 |
| Medline | Medline Industries, Inc. | 40 |
| Cardinal Health | Cardinal Health 200, LLC | 38 |
| Dalton Manual Wheelchair | Dalton Technology, Inc. | 37 |
| Merits | Merits Health Products, Inc. | 35 |
Showing 12 of 226. All products under Wheelchair, Mechanical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133855 | 2014-01-31 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-07-01 | Class II | Device Design | There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame. | 12,142 devices in US, 1,710 devices internationally. | 2017-09-11 |
| 2015-07-27 | Class II | Device Design | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. | 64 total wheelchairs, both models. | 2015-12-10 |
| 2015-07-27 | Class II | Device Design | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. | 64 total wheelchairs, both models | 2015-12-10 |
| 2014-12-19 | Class II | Device Design | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. | 3 | 2015-03-10 |
| 2014-12-19 | Class II | Device Design | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. | 6 | 2015-03-10 |
| 2013-11-11 | Class II | Nonconforming Material/Component | There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk th | 316 units in US, 29 units international | 2014-03-18 |
| 2012-06-26 | Class II | Labeling design | Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner’s manual states that armrest is only designed for resting of forearm. | 14, 035 | 2012-11-01 |
| 2012-01-13 | Not classified | Employee error | One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use. | 1 chair | 2012-02-27 |
| 2009-02-02 | Not classified | Process change control | The stabilizer bar was inadvertently omitted during the manufacturing process. | 23 | 2011-01-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.