Identity
- Trade Name
- Strideway SR Tile FDA UDI
- Generic Name
- Body-surface pressure mapping system FDA UDI
- Device Name
- Includes 5 Standard Resolution Strideway Tiles, 1 pair of End Caps, 1 Rollout Cover, 2 Strideway Power Supply, 2 AC Power Cord for North America, 1 Strideway USB Data Cable, Strideway Software, Equilibration Files, 3160 Sensor Map, 2 Strideway Shipping Cases, PDF of the Users Manual, Printed Copy of the Quick Start Note, and 1 Training Session (USA Only) FDA UDI
- Model / Reference
- 5-Tile Standard Resolution Strideway System FDA UDI
- Description
- Includes 5 Standard Resolution Strideway Tiles, 1 pair of End Caps, 1 Rollout Cover, 2 Strideway Power Supply, 2 AC Power Cord for North America, 1 Strideway USB Data Cable, Strideway Software, Equilibration Files, 3160 Sensor Map, 2 Strideway Shipping Cases, PDF of the Users Manual, Printed Copy of the Quick Start Note, and 1 Training Session (USA Only) FDA UDI
Identifiers
- Catalog Number
- SRSW5 FDA UDI
- Primary DI / UDI-DI
- B970SRSW50 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
Strideway SR Tile 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 648e774c-6466-48ad-8af6-69ba975699b8 34 fields · synced Jun 8, 2026