FDA Inspection
Ekso BionicsEkso Bionics – FDA Inspection, Sep 11, 2015
Record Details
This FDA Inspection record concerns Ekso Bionics, with an inspection on September 11, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ekso Bionics
- Inspection Date
- September 11, 2015
- Product Type
- Devices
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ID · e8d17989-6d8c-45c6-9bce-b4464a0ece90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946397
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.140(b)(6)Other sponsor records required by FDA inadequate
- 21 CFR 812.150(b)(1)Sponsor evaluation rpt not timely, distributed
- 21 CFR 50.25(c)ClincialTrials.gov statement
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ekso Bionics
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2025 | Not classified | San Francisco District Office | |
| June 28, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Ekso Bionics
- FDA Inspection 1273776 - 2025-05-20
- FDA Inspection 1097120 - 2019-06-28
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