Identity
- Trade Name
- P6000 FDA UDI
- Generic Name
- Gait analysis system FDA UDI
- Device Name
- BTS P-6000 is a force platform, which measures ground reaction forces throughout its surface, allowing a deep analysis of a subject’s static postural condition and dynamic postural condition. FDA UDI
- Model / Reference
- 6000 FDA UDI
- Description
- BTS P-6000 is a force platform, which measures ground reaction forces throughout its surface, allowing a deep analysis of a subject’s static postural condition and dynamic postural condition. FDA UDI
Identifiers
- Catalog Number
- BTSP6K FDA UDI
- Primary DI / UDI-DI
- B179P6K FDA UDI
- FDA Product Code
- KHX FDA UDI
- GMDN Term
- Gait analysis system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.1575 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: Gait analysis system
P6000 by Bts Spa — 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
- Bts Spa
Sources (1)
- FDA UDI 464b9a35-b4c5-4293-aaa8-654603c176a7 34 fields · synced Jun 8, 2026