Identity
- Trade Name
- KINVENT FDA UDI
- Generic Name
- Biomechanical function analysis system, force-testing, portable FDA UDI
- Device Name
- Deltas are two independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength. FDA UDI
- Model / Reference
- Deltas V2R01 FDA UDI
- Description
- Deltas are two independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770011995097 FDA UDI
- FDA Product Code
- KHX FDA UDI
- GMDN Term
- Biomechanical function analysis system, force-testing, portable 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Biomechanical function analysis system, force-testing, portable
Kinvent by Kinvent Hellas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biomechanical function analysis system, force-testing, portable.
- Evaluator — BTE TECHNOLOGIES · Class II
- EVJ — BTE TECHNOLOGIES · Class II
- KForce Deltas XL — KINVENT BIOMECANIQUE · Class I
- KINVENT — KINVENT HELLAS · Class I
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
- Kinvent Hellas
Sources (1)
- FDA UDI 82bfec69-a7c7-4c1f-86cd-036e9ac7c5e8 35 fields · synced Jun 8, 2026