Identity
- Trade Name
- Digital Knee® FDA UDI
- Generic Name
- Electronic goniometer/kinesiology sensor FDA UDI
- Device Name
- Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition. FDA UDI
- Model / Reference
- DK-013 FDA UDI
- Description
- Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09413000113839 FDA UDI
- FDA Product Code
- KQX FDA UDI
- GMDN Term
- Electronic goniometer/kinesiology sensor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1500 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electronic goniometer/kinesiology sensor
Digital Knee® by Opum Technologies Services Limited — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Opum Technologies Services Limited
Sources (1)
- FDA UDI 93acbc51-d19d-4ec6-927b-6989c3e7e99d 33 fields · synced Jun 1, 2026