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Trulife

FDA UDI

Class I (US FDA UDI)

by Trulife Limited

Identity

Trade Name
Trulife FDA UDI
Generic Name
Mechanical-resistance external ankle-foot prosthesis FDA UDI
Device Name
LF2 W/PYR 22 R 3/8 114-144# DKBRN FDA UDI
Model / Reference
SLF198-22-R-H6 FDA UDI
Description
LF2 W/PYR 22 R 3/8 114-144# DKBRN FDA UDI

Identifiers

Primary DI / UDI-DI
00645517578187 FDA UDI
FDA Product Code
ISH FDA UDI
GMDN Term
Mechanical-resistance external ankle-foot prosthesis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Category: Mechanical-resistance external ankle-foot prosthesis

A mechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent foot and/or ankle. The principle of operation for dorsiflexion/plantar flexion control is based on media-free mechanical resistance (i.e., mechanical friction/elastic deflection with no fluid or gas operating media).

Similar devices

Also classified as Mechanical-resistance external ankle-foot prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trulife Limited

Sources (1)

  • FDA UDI 846c310c-d19a-46b5-8612-c3c58c4b2b95 33 fields · synced Jul 9, 2026