Data / Medical devices / United States / Ekso Bionics
Ekso Bionics: FDA-registered device maker in San Rafael, CA, United States, 6 510(k) clearances
Ekso Bionics is registered with the FDA (registration 3009495988) in San Rafael, CA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 9, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009495988
- Address
- 101 Glacier Point Suite A, San Rafael, CA, United States, 94901
- Owner or operator
- Ekso Bionics (10050306)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 11, 2018
- Registered through
- 2026
- Brand names listed
- 3DTUTOR; ARMTUTOR; HANDTUTOR; LEGTUTOR, BALANCETUTOR, Ekso, Ekso GT, Ekso Walker, EksoNR, Indego, Nomad
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Components, Exercise | IOD | 1 | Complaint file establishment | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Manufacturer | accessdata.fda.gov |
| Powered Exoskeleton | PHL | 2 | Manufacturer | accessdata.fda.gov |
| Treadmill, Powered | IOL | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 9, 2022 | K220988 | EksoNR | PHL | Substantially Equivalent | Ekso Bionics, Inc. | accessdata.fda.gov |
| June 19, 2020 | K200574 | EksoNR | PHL | Substantially Equivalent | Ekso Bionics, Inc. | accessdata.fda.gov |
| January 31, 2018 | K173530 | Indego(R) | PHL | Substantially Equivalent | Parker-Hannifin Corporation | accessdata.fda.gov |
| September 8, 2017 | K171334 | Indego | PHL | Substantially Equivalent | Parker Hannifin Corporation | accessdata.fda.gov |
| July 19, 2016 | K161443 | Ekso (version 1.1) and Ekso GT (version 1.2) | PHL | Substantially Equivalent | Ekso Bionics, Inc. | accessdata.fda.gov |
| February 26, 2016 | K152416 | Indego | PHL | Substantially Equivalent | Parker Hannifin Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Exoskeleton
- All makers of Orthosis, Limb Brace
- All makers of Walker, Mechanical
- All makers of Treadmill, Powered
- All makers of Components, Exercise
Updated June 9, 2022. 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.