Identity
- Trade Name
- Armeo FDA UDI
- Generic Name
- Virtual-display rehabilitation system, passive-support, upper-limb FDA UDI
- Model / Reference
- Boom FDA UDI
Identifiers
- Catalog Number
- 28976 FDA UDI
- Primary DI / UDI-DI
- 07640174660025 FDA UDI
- FDA Product Code
- IKK FDA UDI
- GMDN Term
- Virtual-display rehabilitation system, passive-support, upper-limb FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Armeo by Hocoma Ag — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Hocoma Ag
Sources (1)
- FDA UDI f4ed356b-ff9e-4f24-9f3b-23fae8cf2b30 34 fields · synced May 31, 2026