Aquatec Ht Adapt (4) for Batt Pwrd Lifts W/ Self-Lift Suct Cups
Aquatec Height Adapters (set of 4) for Battery Powered Lifts w/ self-lifting suction cups
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 | 2019-10-21 |
| Record revised | 2023-09-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Distribution end date | 2019-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15170 | Withdrawn |
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.