FDA Registration
Active
🇺🇸 United States
EKSO BIONICS
Reg #: 3009495988
·
FEI: 3009495988
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- EKSO BIONICS
- Registration Number
- 3009495988
- FEI Number
- 3009495988
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 101 Glacier Point, Suite A
- City
- San Rafael
- State
- CA
- ZIP
- 94901
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173530
Owner / Operator
- Firm Name
- Ekso Bionics
- Operator Number
- 10050306
- Address
- 101 Glacier Point, Suite A
- City
- San Rafael
- State
- CA
- Postal Code
- 94901
- Country
- US
- Correspondent
- Jason Jones
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Exoskeleton | PHL | Class 2 | Physical Medicine | No | 2025-06-30 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2025-06-30 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2025-01-24 |
| Treadmill, Powered | IOL | Class 1 | Physical Medicine | No | 2026-02-17 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2026-02-18 |
Proprietary Names
Indego
Nomad
EksoNR
Ekso Walker
Ekso
Ekso GT
BALANCETUTOR
3DTUTOR; ARMTUTOR; HANDTUTOR; LEGTUTOR
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198