Identity
- Trade Name
- BPMS Evolution FDA UDI
- Generic Name
- Body-surface pressure mapping system FDA UDI
- Device Name
- Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only) FDA UDI
- Model / Reference
- BPMS 1 System (5315 Sensors) FDA UDI
- Description
- Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only) FDA UDI
Identifiers
- Catalog Number
- BCE5315-1 FDA UDI
- Primary DI / UDI-DI
- B970BCE531510 FDA UDI
- FDA Product Code
- JFC FDA UDI
- GMDN Term
- Body-surface pressure mapping system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.1600 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
Yes
FDA UDI
Category: Body-surface pressure mapping system
BPMS Evolution by Tekscan, Inc. — 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
- Tekscan, Inc.
Sources (1)
- FDA UDI daadd4fc-16b5-40dd-bd39-3acb49bd915f 34 fields · synced May 31, 2026