Data / Medical devices / General Use Pneumatic Tourniquet
General Use Pneumatic Tourniquet (QGX): 12 FDA-registered makers in 8 countries
12 establishments in 8 countries are registered with the FDA to make General Use Pneumatic Tourniquet (product code QGX, Class 1, 21 CFR 878.5910). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QGX
- Device class
- 1
- Regulation
- 878.5910
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| India | 2 |
| Israel | 1 |
| United States | 1 |
| Indonesia | 1 |
| Canada | 1 |
| Singapore | 1 |
| United Kingdom | 1 |
Makers of General Use Pneumatic Tourniquet
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 |
|---|---|---|---|---|---|---|---|---|
| Auckland Medical Technology (Sichuan) Co. Ltd | Luzhou Sichuan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| First Care Products Ltd. | Rosh HaAyin Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Golden Hour Medical | Boca Raton, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kossel Medtech (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Risenmed Technology Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. SP Manufacturing | Batam Riau, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ring Rescue Inc | Dartmouth Nova Scotia, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SP Manufacturing Pte Ltd | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SecondPerspective, Ltd. | Edinburgh Scotland, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tynor Orthotics (P) Ltd. | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vistar Medical Supplies Co., Ltd. | SHENZHEN Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.