Data / Medical devices / Powered Exoskeleton
Powered Exoskeleton (PHL): 7 FDA-registered makers in 6 countries
7 establishments in 6 countries are registered with the FDA to make Powered Exoskeleton (product code PHL, Class 2, 21 CFR 890.3480). 7 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on September 2, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PHL
- Device class
- 2
- Regulation
- 890.3480
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Israel | 1 |
| France | 1 |
| Japan | 1 |
| Canada | 1 |
| South Korea | 1 |
Makers of Powered Exoskeleton
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 |
|---|---|---|---|---|---|---|---|---|
| Ekso Bionics | San Rafael, CA, United States | Manufacturer | 6 | June 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| Lifeward LTD. | Upper Yokneam Northern, Israel | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 5 | March 12, 2025 | 0 | 2 | 0 | api.fda.gov |
| Wandercraft | Paris Ile-de-France, France | Complaint file establishment, Manufacturer | 4 | August 3, 2026 | 0 | 1 | 0 | api.fda.gov |
| Wandercraft Incorporated | New York, NY, United States | Manufacturer | 4 | August 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cyberdyne Inc. | Tsukuba Ibaraki, Japan | Complaint file establishment, Manufacturer | 2 | May 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| B-Temia.inc | St-Augustin-de-Desmaures Quebec, Canada | Manufacturer | 1 | September 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cosmo Robotics Co., Ltd | Seoul, South Korea | Manufacturer | 1 | July 16, 2021 | 0 | 0 | 0 | api.fda.gov |
Updated September 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.