Identity
- Trade Name
- KEEOGO - CLINICIAN KIT FDA UDI
- Generic Name
- Programmable ambulation exoskeleton, clinical FDA UDI
- Device Name
- Powered walking assistance device FDA UDI
- Model / Reference
- 5062601 FDA UDI
- Description
- Powered walking assistance device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540162060007 FDA UDI
- 510(k) Number
- K201539 FDA UDI
- FDA Product Code
- PHL FDA UDI
- GMDN Term
- Programmable ambulation exoskeleton, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Programmable ambulation exoskeleton, clinical
Keeogo - Clinician Kit by B-Temia Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- B-Temia Inc
Sources (1)
- FDA UDI dbff76ef-30b4-43de-b064-8aa12f265086 35 fields · synced May 30, 2026