Identity
- Trade Name
- Digitsole Pro FDA UDI
- Generic Name
- Gait analysis system FDA UDI
- Model / Reference
- DSPS001FPT-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700565774640 FDA UDI
- FDA Product Code
- ISD FDA UDI
- GMDN Term
- Gait analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gait analysis system
Digitsole Pro by Digitsole — 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
- Digitsole
Sources (1)
- FDA UDI c1224726-c219-4d48-96b5-7b3acaed5ffd 32 fields · synced May 29, 2026