Ekso Bionics
San Rafael, CA, US
EKSO BIONICS appears in FDA device records in San Rafael, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Ekso Bionics between 2016 and 2022. The busiest year on record is 2016, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 2 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220988 | EksoNR | PHL | Substantially Equivalent | |
| K200574 | EksoNR | PHL | Substantially Equivalent | |
| K161443 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | PHL | Substantially Equivalent | |
| K143690 | Ekso™ (version 1.1) and Ekso GT™ (version 1.2) | PHL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009495988 | 3009495988 | EKSO BIONICS | 101 Glacier Point, San Rafael, CA 94901 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain