Question 1

What types of medical devices does Trulife Ltd manufacture?

Accepted Answer

Trulife Ltd specialises in ankle-foot orthoses (AFOs) for both adults and children, including adjustable and fixed-frame designs like anterior and lateral AFOs in various sizes. Their product range also covers adjustable crutches for adults and children, wheeled support frames, and domestic height-adjustable frames. These devices are primarily designed to enhance stability and mobility for lower-limb support.

Question 2

Where is Trulife Ltd based, and how does this affect its regulatory compliance?

Accepted Answer

Trulife Ltd is based in the United Kingdom, which means its devices must comply with UK and EU regulatory standards. Since their products fall under Class I medical devices, they are subject to general safety and performance requirements under EU regulations (e.g., MDR/AIMD) and FDA guidelines in the US. The company’s location influences its adherence to these frameworks, ensuring devices meet applicable classification and registration criteria.

Question 3

Which regulatory registries list Trulife Ltd’s devices, and why are these important?

Accepted Answer

Trulife Ltd’s devices are listed in the euamed registry for EU compliance and the FDA 510(k) registry for US clearance. These registries confirm that the devices meet regulatory requirements for market placement. For Class I devices, listing in these systems ensures transparency and compliance with mandatory reporting standards, helping healthcare providers and authorities verify the device’s authorised status.

Question 4

How are Trulife Ltd’s devices classified, and what does this classification mean?

Accepted Answer

Trulife Ltd’s devices are classified as Class I medical devices in both the EU and the US. This classification applies to low-risk products like orthoses, crutches, and support frames, which generally pose minimal risk to patients. Class I devices still require compliance with basic safety and performance standards but typically undergo less rigorous pre-market scrutiny than higher-risk categories.

Device	Model / Reference	Registries	Class	Status
Matrix AFO - Medium Right	FH200R03	EUDAMEDFDA UDI	Class I	Active
Matrix Max Raw AFO (One Size Left)	FH225-L	EUDAMEDFDA UDI	Class I	Active
Compact Adjustable Height Frame 72-82cm	RM551572	EUDAMED	Class I	Active
Budget Elbow Crutches Pair SGL Adjmt MED	RM516100	EUDAMED	Class I	Active
Large wheeled walking frame	SMM003	EUDAMED	Class I	Active
Large narrow walking frame	SMM012	EUDAMED	Class I	Active
Matrix Max AFO (Large Left)	FH250L04	EUDAMEDFDA UDI	Class I	Active
Trulife Ergo Handle Adjustable Walking Stick Left Handed 74-102cm	RM492000	EUDAMED	Class I	Active
M-Pace Medial AFO - Left Small	FH400L02	EUDAMEDFDA UDI	Class I	Active
Medium narrow wheeled walking frame	SMM008	EUDAMED	Class I	Active
Trulife Budget Adjustable Height Walking Stick 74-102cm	RM490574	EUDAMED	Class I	Active
Pair SGL Adjmt STD Elbow Crutches	RM510700	EUDAMED	Class I	Active
U-Pace, Universal Posterior Medial AFO – Left	FH460L01	EUDAMED	Class I	Active
CHILDRENS DBL ADJ CRUTCH BLUE 10H 41-64cm	RJ781801	EUDAMED	Class I	Active
Hospital Adjustable Height Wheeled Frame 77-84cm	RM564077	EUDAMED	Class I	Active
A-Pace Anterior AFO – Large/X Large Left	FH500L02	EUDAMED	Class I	Active
Slimline Adjustable Height Wheeled Frame 88-98cm	RM563588	EUDAMED	Class I	Active
L-Pace Lateral AFO - Right Medium	FH450R03	EUDAMEDFDA UDI	Class I	Active
Matrix Max 2 AFO - Large Right	FH260R04	EUDAMEDFDA UDI	Class I	Active
Heavy Duty Adjustable Height Frame 87-97cm 35st MX/USER	RM597587	EUDAMED	Class I	Active
Small gutter frame	SMM016	EUDAMED	Class I	Active
Matrix AFO - Medium Left	FH200L03	EUDAMEDFDA UDI	Class I	Active
Trulife Combi fischer stick left hand	SMM535	EUDAMED	Class I	Active
Domestic Adjustable Height Wheeled Frame 72-81cm	RM563373	EUDAMED	Class I	Active
Trough Frame Adjustable Height Wheeled 98-108cm	RM585098	EUDAMED	Class I	Active
Trough Frame Adjustable Height Wheeled 83-93cm	RM585073/RED	EUDAMED	Class I	Active
Matrix SuperMax AFO (Medium Right)	FH270R03	EUDAMEDFDA UDI	Class I	Active
Matrix AFO - Large Right	FH200R04	EUDAMEDFDA UDI	Class I	Active
U-Pace, Universal Posterior Lateral AFO – Left	FH460L02	EUDAMED	Class I	Active
Hemi Grip Walking Frame - Small	SMM024	EUDAMED	Class I	Active
Childs Walking Frame GOLD Coated Wheeled	RJ790600	EUDAMED	Class I	Active
Large gutter frame	SMM018	EUDAMED	Class I	Active
Hemi Grip Walking Frame - Medium	SMM025	EUDAMED	Class I	Active
L-Pace Lateral AFO - Left Medium	FH450L03	EUDAMEDFDA UDI	Class I	Active
Pair DBL Adjmt STD Elbow Crutches BRONZE	RM518700	EUDAMED	Class I	Active
Matrix Max AFO (X Large Left)	FH250L05	EUDAMEDFDA UDI	Class I	Active
Matrix AFO - Small Right	FH200R02	EUDAMEDFDA UDI	Class I	Active
Trulife Tripod Handle to Floor: 750-1005mm MUW: 25st 160kg	SMM046	EUDAMED	Class I	Active
Pair DBL Adjmt STD Elbow Crutches BLACK	RM518600	EUDAMED	Class I	Active
A-Pace Anterior AFO – Small/Medium Left	FH500L01	EUDAMED	Class I	Active
Matrix Max AFO (Medium Left)	FH250L03	EUDAMEDFDA UDI	Class I	Active
U-Pace, Universal Posterior Lateral AFO – Right	FH460R02	EUDAMED	Class I	Active
Pair 138cm H/Duty Fixed Height Crutches	RM520300	EUDAMED	Class I	Active
Trough Frame Adjustable Height Wheeled 73-83cm	RM585073	EUDAMED	Class I	Active
Matrix Max AFO (Small Left)	FH250L02	EUDAMEDFDA UDI	Class I	Active
Budget Elbow Crutches Pair DBL Adjmt MED	RM517100	EUDAMED	Class I	Active
Children's wheeled walking frame	SMM00KW	EUDAMED	Class I	Active
Compact Adjustable Height Frame 79-89cm	RM551579	EUDAMED	Class I	Active
Small narrow wheeled walking	SMM007	EUDAMED	Class I	Active
Hospital Adjustable Height Wheeled Frame 87-94cm	RM564087	EUDAMED	Class I	Active

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