Celebrity X 3 Wheel
Catalogue number S4001/SC4001, listed by Pride Mobility Products Corp., United States, under Vehicle, Motorized 3-Wheeled. 41 manufacturers in China are registered for this product code.
41manufacturers in China registered for this device type
1catalogue number
10510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Zhejiang (14), Jiangsu (9), Guangdong (8). 10 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 |
| Chiaphua Components (Jiangxi) Limited | Yichun | Jiangxi | Contract manufacturer | 23 |
| Feishen Group Co., Ltd. | Yongkang | Zhejiang | Contract manufacturer | 22 |
| Guangdong Marshell Electric Vehicle Co., Ltd. | Zhaoqing | Guangdong | Contract manufacturer | 22 |
| Zhejiang Linix Motor Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 4 |
| Jinhua Ruidi Vehicle Industry Co Ltd | Zhejiang | Zhejiang | Contract manufacturer | 2 |
| Suzhou Green Pine Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Dongguan Tetro Ltd (China) | Dongguan | Guangdong | Contract manufacturer | 1 |
| Guangdong Zhanyuan Smart Science and Technology Co., Ltd. | Dalang Town, Dongguan | Guangdong | Contract manufacturer | 1 |
| Shanghai Chien TI Motor Co., Ltd. | Jia Ding Dist. | Shanghai | Contract manufacturer | 1 |
| Merits Healthcare Industries. (Suzhou) Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 31 |
| Global Fabtech Wheel Chair (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 15 |
Showing 12 of 41. All 41 manufacturers in China registered for Vehicle, Motorized 3-Wheeled
Record
| Listed by | Pride Mobility Products Corp., United States |
|---|---|
| FDA product code | INI |
| Device type | Vehicle, Motorized 3-Wheeled |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-19 |
| Record revised | 2023-04-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S4001/SC4001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Merits | Merits Health Products, Inc. | 58 |
| Drive | Drive DeVilbiss Healthcare | 38 |
| Drivemedical | Drive DeVilbiss Healthcare | 38 |
| Mobility Scooter | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | 33 |
| Freerider | Freerider, Corp. | 23 |
| Shoprider | Pihsiang Machinery Manufacturing Co., Ltd. | 17 |
| Heartway Medical Products Co., Ltd. | Heartway Medical Products Co., Ltd. | 16 |
| CTM Mobility Scooter | C.T.M. Homecare Product, Inc. | 14 |
| Pacesaver | Burke, Inc. | 14 |
| CTM | Chien TI Enterprise Co., Ltd. | 13 |
| Scout | Drive DeVilbiss Healthcare | 12 |
| Vive Mobility | Vive Health LLC | 12 |
Showing 12 of 149. All products under Vehicle, Motorized 3-Wheeled
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092088 | 2009-07-16 |
| K091113 | 2009-05-11 |
| K090805 | 2009-04-03 |
| K090524 | 2009-03-19 |
| K072165 | 2007-08-17 |
| K071949 | 2007-08-01 |
| K063389 | 2006-11-17 |
| K062160 | 2006-09-12 |
| K003058 | 2001-03-08 |
| K003059 | 2001-03-01 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2011-06-22 | Not classified | Nonconforming Material/Component | Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride’s Engineering drawings. | 2014-11-20 | |
| 2011-06-22 | Not classified | Nonconforming Material/Component | Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride’s Engineering drawings. | 2014-11-20 | |
| 2010-11-26 | Class II | Nonconforming Material/Component | The main harness connector was manufactured without the required back shield sealing protection. As a result, there is the potential for water to seep through the nonconforming harness. | 186 | 2013-03-22 |
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.