TiLite
14 catalogue numbers from Aero T, listed by Tilite, under Wheelchair, Mechanical. 46 manufacturers in China are registered for this product code.
46manufacturers in China registered for this device type
14catalogue numbers in this listing
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 | Tilite |
|---|---|
| FDA product code | IOR |
| Device type | Wheelchair, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3850 |
| 510(k) | K990358 |
| Record published | 2020-09-23 |
| Record revised | 2023-12-18 (version 3) |
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 |
|---|---|---|
| Aero T | In distribution | |
| Twist | In distribution | |
| ZR | In distribution | |
| 2GX | In distribution | |
| Aero X | In distribution | |
| Pilot | In distribution | |
| TX | In distribution | |
| TiLite X | In distribution | |
| ZRA | In distribution | |
| CR1 | In distribution | |
| TiLite Z | In distribution | |
| TR | In distribution | |
| TRA | In distribution | |
| Aero Z | 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
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Tisport, LLC | 510(k) number | 2021-09-24 | Class II | Component change control | Some affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may not be configured in the right orientation to perform as intended if involved in a motor vehicle accident. Some affected wheelchairs | 5373 | |
| Tisport, LLC | 510(k) number | 2018-09-11 | Class II | Component design/selection | The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards. | 1,452 wheelchairs | 2022-07-29 |
| Tisport, LLC | 510(k) number | 2011-07-05 | Not classified | Component design/selection | The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2 mechanical wheelchairs have shown a tendency to fail due to the head of the bolt being sheared off. | 1,037 units | 2012-07-27 |
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.