Identity
- Trade Name
- K-Deltas EUDAMEDKForce Deltas FDA UDI
- Generic Name
- Biomechanical function analysis system, force-testing, portable FDA UDI
- Device Name
- KForce Deltas EUDAMEDK Deltas are two large independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength FDA UDI
- Model / Reference
- MP.33.03.FN EUDAMEDK Deltas V3 FDA UDI
- Description
- K Deltas are two large independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770011995417 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03770011995417 EUDAMED
- FDA Product Code
- KHX FDA UDI
- EMDN Code
- Z12062601 DYNAMOMETRIC PLATFORMS EUDAMED
- GMDN Term
- Biomechanical function analysis system, force-testing, portable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.1575 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
K-Deltas by Kinvent Biomecanique — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03770011995417 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KINVENT Biomecanique
- EUDAMED SRN
- FR-MF-000031884
Sources (2)
- EUDAMED 129b0c7e-0ddc-493b-b6ed-84752ac73592 61 fields · synced Jun 19, 2026
- FDA UDI cbaf5916-ac63-4505-b712-b9d05b9477c7 35 fields · synced May 29, 2026