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KForce Deltas XL

FDA UDI

Class I (US FDA UDI)

by Kinvent Biomecanique

Identity

Trade Name
KForce Deltas XL FDA UDI
Generic Name
Biomechanical function analysis system, force-testing, portable FDA UDI
Device Name
K Deltas are two large independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength FDA UDI
Model / Reference
K Deltas XL 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
03770011995608 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

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

Category: Biomechanical function analysis system, force-testing, portable

KForce Deltas XL by Kinvent Biomecanique — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biomechanical function analysis system, force-testing, portable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kinvent Biomecanique

Sources (1)

  • FDA UDI a59d13c2-bf5e-4010-a7f1-9a56b9e269e9 35 fields · synced Jun 8, 2026