Identity
- Trade Name
- DataLINK DLK900 FDA UDI
- Generic Name
- Biomechanical function analysis system, motion-tracking FDA UDI
- Device Name
- DataLINK (DLK900) is an on-line general purpose subject worn programmable Data Acquisition System allowing the user to collect both analog and digital data from a wide range of wired sensors including Biometrics' Goniometers, Torsiometers, active EMG sensors, Accelerometers, Pinchmeters, Hand Dynamometers and Contact Switches. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. FDA UDI
- Model / Reference
- DLK900 FDA UDI
- Description
- DataLINK (DLK900) is an on-line general purpose subject worn programmable Data Acquisition System allowing the user to collect both analog and digital data from a wide range of wired sensors including Biometrics' Goniometers, Torsiometers, active EMG sensors, Accelerometers, Pinchmeters, Hand Dynamometers and Contact Switches. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13. FDA UDI
Identifiers
- Catalog Number
- DataLINK DLK900 - metal connectors FDA UDI
- Primary DI / UDI-DI
- 05060481692052 FDA UDI
- FDA Product Code
- KQX FDA UDIIKK FDA UDI
- GMDN Term
- Biomechanical function analysis system, motion-tracking FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1500 FDA UDI890.1925 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
No
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
Category: Biomechanical function analysis system, motion-tracking
DataLINK DLK900 by Biometrics 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
- Biometrics Limited
Sources (1)
- FDA UDI cc8c0663-96bd-4d7a-86f4-35e17cd21678 34 fields · synced May 31, 2026