Surgistool
Catalogue number 0830, listed by Stryker GmbH, Switzerland, under Stool, Operating-Room. 16 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
| Hangzhou Dunli Medical Instruments Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 16 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Zhongshan A&E Machinery Industry Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 25 |
| Better Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 24 |
| Hangzhou Zhongzhi Industry Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Foshan Fuzikon Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 21 |
| Foshan Suncare Medical Products Co Ltd | Foshan | Guangdong | Contract manufacturer | 20 |
| Chants (Foshan) Technology Co., Ltd. | Foshan | Guangdong | Repacker / relabeller | 16 |
Showing 12 of 16. All 16 manufacturers in China registered for Stool, Operating-Room
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | FZM |
| Device type | Stool, Operating-Room |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-10 |
| Record revised | 2025-12-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0830 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Intensa | GF Health Products, Inc | 281 |
| MTI | Tech Industries. Inc. | 228 |
| Assembly Required Distributors | Assembly Required Distributors Inc | 26 |
| Doctor stool ak 445 | Akrus GmbH & Co. KG | 19 |
| Stool, Operating-Room | MID Central Medical | 19 |
| Imperial Staddle (Neurosurgery) Tables | Imperial Surgical Ltd. | 16 |
| Doctor stool ak 447 | Akrus GmbH & Co. KG | 11 |
| Setmark | Setmark Inc. | 11 |
| Doctor stool ak 446 | Akrus GmbH & Co. KG | 10 |
| Ufsk-Osys Assistant’s chair | Ufsk-International Osys Gmbh | 7 |
| Tech-Med | Dukal LLC | 6 |
| Brydan Medical | Brydan Medical Holdings | 6 |
Showing 12 of 50. All products under Stool, Operating-Room
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker GmbH | UDI-DI | 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 | 4 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.