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 Max 2 AFO - Large Left	FH260L04	EUDAMEDFDA UDI	Class I	Active
A-Pace Anterior AFO – Large/X-Large Right	FH500R02	EUDAMED	Class I	Active
Matrix Max 2 AFO - X Large Right	FH260R05	EUDAMEDFDA UDI	Class I	Active
Combi crutch double adjustable adult Extra long comfy handle	SMM529	EUDAMED	Class I	Active
L-Pace Lateral AFO - Left Small	FH450L02	EUDAMEDFDA UDI	Class I	Active
Matrix SuperMax AFO (Medium Left)	FH270L03	EUDAMEDFDA UDI	Class I	Active
Trough Frame Adjustable Height Wheeled 98-108cm RED	RM585098/RED	EUDAMED	Class I	Active
L-Pace Lateral AFO - Right Large	FH450R04	EUDAMEDFDA UDI	Class I	Active
Pair DBL Adjmt STD Elbow Crutches GREEN	RM518300	EUDAMED	Class I	Active
CHILDRENS DBL ADJ CRUTCH ORANGE 10H 41-64cm	RJ781804	EUDAMED	Class I	Active
Domestic Adjustable Height Frame 79-89cm	RM553579	EUDAMED	Class I	Active
Domestic Adjustable Height Frame 72-82cm	RM553572	EUDAMED	Class I	Active
CHILDRENS DBL ADJ CRUTCH GREEN 10H 41-64cm	RJ781800	EUDAMED	Class I	Active
Pair DBL Adjmt STD Elbow Crutches BLUE	RM518200	EUDAMED	Class I	Active
Trough Frame Adjustable Height Wheeled 83-93cm RED	RM585083/RED	EUDAMED	Class I	Active
U-Pace, Universal Posterior Medial AFO – Right	FH460R01	EUDAMED	Class I	Active
Hospital Adjustable Height Frame 86-93cm	RM552686	EUDAMED	Class I	Active
Pair DBL Adjmt STD Elbow Crutches GOLD	RM518800	EUDAMED	Class I	Active
Pair DBL Adjmt MED Elbow Crutches	RM515000	EUDAMED	Class I	Active
Matrix SuperMax AFO (X Large Right)	FH270R05	EUDAMEDFDA UDI	Class I	Active
Compact Adjustable Height Wheeled Frame 88-98cm	RM563088	EUDAMED	Class I	Active
Budget Elbow Crutches Pair SGL Adjmt XLG	RM516200	EUDAMED	Class I	Active
Matrix SuperMax AFO (Small Left)	FH270L02	EUDAMEDFDA UDI	Class I	Active
Matrix Max AFO (Small Right)	FH250R02	EUDAMEDFDA UDI	Class I	Active
Slimline Adjustable Height Wheeled Frame 73-83cm	RM563573	EUDAMED	Class I	Active
Trulife Tetrapod Handle to Floor: 750-1005mm MUW: 25st 160kg	SMM044	EUDAMED	Class I	Active
L-Pace Lateral AFO - Left X Large	FH450L05	EUDAMEDFDA UDI	Class I	Active
Small walking frame	SMM004	EUDAMED	Class I	Active
Trulife Combi walking stick height adjustable	SMM539	EUDAMED	Class I	Active
Budget Elbow Crutches Pair DBL Adjmt STD	RM517000	EUDAMED	Class I	Active
Combi crutch double adjustable adult extra long	SMM500	EUDAMED	Class I	Active
L-Pace Lateral AFO - Left Large	FH450L04	EUDAMEDFDA UDI	Class I	Active
Matrix Max AFO (Medium Right)	FH250R03	EUDAMEDFDA UDI	Class I	Active
Single Trough Frame (83cm - 93cm)	RM587100	EUDAMED	Class I	Active
Trulife Budget Adjustable Height Walking Stick 74-102cm Red	RM490574/RED	EUDAMED	Class I	Active
L-Pace Lateral AFO - Right Small	FH450R02	EUDAMEDFDA UDI	Class I	Active
Duet	K934970	FDA 510(k)	Class I	Active
M-Pace Medial AFO - Left Large	FH400L04	EUDAMEDFDA UDI	Class I	Active
Large narrow wheeled walking frame	SMM009	EUDAMED	Class I	Active
M-Pace Medial AFO - Right Small	FH400R02	EUDAMEDFDA UDI	Class I	Active
Matrix AFO - Small Left	FH200L02	EUDAMEDFDA UDI	Class I	Active
Slimline Adjustable Height Wheeled Frame 80-90cm	RM563580	EUDAMED	Class I	Active
Small wheeled walking frame	SMM001	EUDAMED	Class I	Active
Trough Frame Adjustable Height 98-108cm	RM574598	EUDAMED	Class I	Active
Childs Walking Frame GREEN Coated Wheeled	RJ790700	EUDAMED	Class I	Active
Slimline Adjustable Height Frame 87-97cm	RM552087	EUDAMED	Class I	Active
L-Pace Lateral AFO - Right X Large	FH450R05	EUDAMEDFDA UDI	Class I	Active
Pair DBL Adjmt STD Elbow Crutches RED	RM518100	EUDAMED	Class I	Active
M-Pace Medial AFO - Right Medium	FH400R03	EUDAMEDFDA UDI	Class I	Active
Domestic Adjustable Height Wheeled Frame 88 -98cm RED	RM563388/RED	EUDAMED	Class I	Active

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