Data / Medical devices / Twister, Brace Setting
Twister, Brace Setting (ITO): 15 FDA-registered makers in 12 countries
15 establishments in 12 countries are registered with the FDA to make Twister, Brace Setting (product code ITO, Class 1, 21 CFR 890.3410). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on May 2, 1980, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ITO
- Device class
- 1
- Regulation
- 890.3410
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| India | 2 |
| Pakistan | 1 |
| Austria | 1 |
| Japan | 1 |
| China | 1 |
| Mexico | 1 |
| Israel | 1 |
| Norway | 1 |
| Taiwan | 1 |
| Belgium | 1 |
| France | 1 |
Makers of Twister, Brace Setting
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 |
|---|---|---|---|---|---|---|---|---|
| Becker Orthopedic Appliance Co. | Troy, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare Austria GmbH & Co OG | ZIPF Oberosterreich, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare Japan Corporation | HINO-SHI Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems, Israel Ltd. | Haifa, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Parallel Design, Inc. | Phoenix, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Vingmed Ultrasound A/S | HORTEN Vestfold, Norway | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiundar Industrial Co., Ltd. | SHULIN CITY Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orfit Industries NV | WIJNEGEM Antwerpen, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parallel Design SAS | Valbonne, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro Ge Medical Device Manufacturing Private Limited | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro GE Healthcare Private Ltd. | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 2, 1980. 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.