Ocean VIP Ergo Dir. Lock
Catalogue number 1604019, listed by Invacare GmbH, Germany, under Chair, Adjustable, Mechanical. 46 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (20), Jiangsu (12), Zhejiang (7). 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 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
| 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 |
| Foshan Huafukang Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 19 |
| Zhejiang Kelongwei Medical Equipment Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 10 |
| Three Bears (Jiangsu) Healthcare Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Fran Wheel Enterprise Co., Ltd. | Shen Zhen | Guangdong | Contract manufacturer | 4 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
Showing 12 of 46. All 46 manufacturers in China registered for Chair, Adjustable, Mechanical
Record
| Listed by | Invacare GmbH, Germany |
|---|---|
| FDA product code | INN |
| Device type | Chair, Adjustable, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3100 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-10-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1604019 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jenx | Jenx Limited | 612 |
| Plus | Pressalit A/S | 137 |
| R82 | R82 A/S | 88 |
| Winco | Winco Mfg., LLC | 49 |
| Etac Supply Center AB | Etac Supply Center AB | 42 |
| Champion | Champion Manufacturing Inc. | 40 |
| Staxi | Staxi Corporation | 29 |
| Clinton Industries | Clinton Industries, Inc | 13 |
| JMU | JMU Dental, Inc | 12 |
| Raz | RAZ Design Inc. | 12 |
| ActiveAid | Altimate Medical, Inc. | 11 |
| Staxi | Three Bears (Jiangsu) Healthcare Technology Co., Ltd. | 9 |
Showing 12 of 157. All products under Chair, Adjustable, Mechanical
Recalls
2 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 |
|---|---|---|---|---|---|
| 2014-06-25 | Class II | Device Design | The Aquatec Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result in the Fixed Backrest becoming detached from the frame. | 465 units | 2015-04-15 |
| 2013-08-31 | Class II | Nonconforming Material/Component | The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N, when the product is used in a reclined position and or tilted pos | 538 (US only) 3317 (Total) | 2014-09-15 |
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.