Havasu
Catalogue number 1460-035-021, listed by Stryker GmbH, Switzerland, 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | INN |
| Device type | Chair, Adjustable, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3100 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-30 |
| Record revised | 2023-10-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 140 °F; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 30 to 85 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1460-035-021 | 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
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 |
|---|---|---|---|---|
| 2021-05-12 | Class II | Under Investigation by firm | Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not b | 2 units |
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.