MyOn Jr.
Catalogue number MYONJR,, listed by Invacare GmbH, Germany, under Wheelchair, Mechanical. 46 manufacturers in China are registered for this product code.
46manufacturers in China registered for this device type
1catalogue number
32510(k) clearances naming this product 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 | Invacare GmbH, Germany |
|---|---|
| FDA product code | IOR |
| Device type | Wheelchair, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3850 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K930803 |
| Record published | 2019-06-10 |
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 |
|---|---|---|
| MYONJR, | 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 |
|---|---|
| K181090 | 2018-11-14 |
| K162621 | 2017-04-17 |
| K162692 | 2016-12-28 |
| K162686 | 2016-12-28 |
| K162696 | 2016-12-28 |
| K152536 | 2016-01-05 |
| K060582 | 2006-03-16 |
| K041072 | 2004-05-12 |
| K012370 | 2001-08-03 |
| K012167 | 2001-08-01 |
| K002317 | 2000-08-25 |
| K002170 | 2000-08-04 |
| K000174 | 2000-02-18 |
| K990157 | 1999-02-03 |
| K984447 | 1999-01-08 |
| K982336 | 1998-08-21 |
| K951138 | 1995-03-20 |
| K930803 | 1994-03-24 |
| K935398 | 1994-03-01 |
| K934646 | 1993-12-15 |
| K921847 | 1992-05-22 |
| K920391 | 1992-02-11 |
| K914553 | 1991-10-28 |
| K894136 | 1989-07-25 |
| K884932 | 1988-12-12 |
| K884931 | 1988-12-12 |
| K881951 | 1988-05-19 |
| K881762 | 1988-05-04 |
| K864901 | 1986-12-24 |
| K853424 | 1985-11-05 |
| K842232 | 1984-06-22 |
| K801557 | 1980-07-21 |
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.