Data / Medical devices / Chair, Surgical, Non-Electrical
Chair, Surgical, Non-Electrical (FZK): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Chair, Surgical, Non-Electrical (product code FZK, Class 1, 21 CFR 878.4950). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on December 12, 1996, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FZK
- Device class
- 1
- Regulation
- 878.4950
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| United States | 4 |
| Mexico | 1 |
| Israel | 1 |
| India | 1 |
Makers of Chair, Surgical, Non-Electrical
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| A & I Industries Ltd | FOSHAN CITY Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GF Health Products, Inc. | Fond du Lac, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GUILIN YIKESHI Medical Device CO LTD | Guilin Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JEDMED Instrument Company | Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lakong Medical Devices Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Savion Industries (1987), Ltd. | ASHDOD Southern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Greeloy Industry Co., Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Poly Engineering Pvt. Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venus Concept Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 12, 1996. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.