Identity
- Trade Name
- DataLOG Management Software (Version 10) FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- The DataLOG Management Software allows the user to set up the DataLOG communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software. Software is available in English, Chinese, and Japanese. FDA UDI
- Model / Reference
- 410xx-00 FDA UDI
- Description
- The DataLOG Management Software allows the user to set up the DataLOG communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software. Software is available in English, Chinese, and Japanese. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481691673 FDA UDI
- FDA Product Code
- IKK FDA UDIKQX FDA UDI
- GMDN Term
- Kinesiology ambulatory recorder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 FDA UDI888.1500 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Kinesiology ambulatory recorder
DataLOG Management Software (Version 10) by Biometrics Limited — 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
- Biometrics Limited
Sources (1)
- FDA UDI c70e3539-096c-49b0-989d-5d5adc8ba5d0 33 fields · synced May 31, 2026