Data / Medical devices / Orthosis, Limb, For Back Pain
Orthosis, Limb, For Back Pain (PMV): 13 FDA-registered makers in 9 countries
13 establishments in 9 countries are registered with the FDA to make Orthosis, Limb, For Back Pain (product code PMV, Class 1, 21 CFR 890.3475). 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 February 26, 2016, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PMV
- Device class
- 1
- Regulation
- 890.3475
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| India | 2 |
| United States | 2 |
| Italy | 1 |
| Australia | 1 |
| Egypt | 1 |
| South Korea | 1 |
| Cambodia | 1 |
| Taiwan | 1 |
Makers of Orthosis, Limb, For Back Pain
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 |
|---|---|---|---|---|---|---|---|---|
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Lee-Mat Sports Technology Co., Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurosirel S.P.A | Cusago Milano, Italy | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Leamai Medical Instrument Co., Ltd. | Hengshui Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Matana Pty Ltd | POINT COOK, Victoria, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracle Medical Industries | El Obour City Al Qahirah, Egypt | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neomed Co., Ltd. | Saha-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Products, Inc. | Defuniak Spgs, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tommie Copper Inc | Mount Kisco, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WP Sports (cambodia) Co., Ltd. | Bavet City Svay Rieng, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasco Enterprise Corp. | Chiayi County Chiayi(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 26, 2016. 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.