Question 1

What types of medical devices does Pro 11 Wellbeing Limited manufacture?

Accepted Answer

Pro 11 Wellbeing Limited specialises in Class I orthotic devices primarily focused on foot support and alignment. Their product range includes full-length and three-quarter-length orthotic insoles, prescription-level insoles, memory foam insoles, shock-absorbing sports insoles, dual-gel ankle sleeves, and night splints designed for conditions like plantar fasciitis and Achilles tendonitis. They also offer orthotic sandals with built-in arch support.

Question 2

Where is Pro 11 Wellbeing Limited based?

Accepted Answer

Pro 11 Wellbeing Limited is based in the United Kingdom. The company’s headquarters and operations are located within the UK, which is reflected in its regulatory and manufacturing activities.

Question 3

Are Pro 11 Wellbeing Limited’s devices listed in any regulatory registries?

Accepted Answer

Yes, Pro 11 Wellbeing Limited’s devices are registered in the eudamed database, which is the European Union’s centralised registry for medical devices. This registration is required for Class I devices to demonstrate compliance with EU regulations and ensure traceability.

Question 4

How are Pro 11 Wellbeing Limited’s devices classified under EU regulations?

Accepted Answer

All of Pro 11 Wellbeing Limited’s devices fall under Class I classification in the EU. This classification applies to low-risk devices, such as orthotic insoles, ankle sleeves, and night splints, which are intended for general foot support, pain relief, or minor musculoskeletal conditions without significant health risks.

Device	Model / Reference	Registries	Class	Status
Pro11 Wellbeing Worx Series Orthotic Insoles	B09MFZTWHX	EUDAMED	Class I	Active
Pro 11 Wellbeing Pro Series Orthotic Insoles	B09MG1T2CD	EUDAMED	Class I	Active
The Titan - Dual Shock Sports Orthotic Insoles by Pro11 Wellbeing	B07BJ2M4QL	EUDAMED	Class I	Active
Pro11 Wellbeing Memory Foam Orthotic Insoles	B00X7OS9FE	EUDAMED	Class I	Active
Orthotic Sandals With Great Arch Support	B07B54CQS5	EUDAMED	Class I	Active
Pro11 Wellbeing Plantar Series - Full Length Orthotic Insoles	B0CH2Y91J3	EUDAMED	Class I	Active
Dual Gel ankle sleeves	B07TMQJC33	EUDAMED	Class I	Active
Pro11 Wellbeing Plantar Series - 3/4 Length Orthotic Insoles	B0CJYDPGRL	EUDAMED	Class I	Active
Pro 11 Night Splint Support Wrap For Treatment Of Plantar Fasciitis	B07JMBFYR3	EUDAMED	Class I	Active
Adjustable Night Splint for Treatment of Plantar Fasciitis and Achilles Tendonitis	B0DK5K78RR	EUDAMED	Class I	Active
Pro11 Miniluxe Premium Pro Prescription Level Foot Orthotic Insoles	B09L8MDF4Q	EUDAMED	Class I	Active
Pro 11 Wellbeing Ultra Air Orthotic Insoles	B09MFY3F55	EUDAMED	Class I	Active
Pro 11 Wellbeing Night Splint Sock	B00SPS6DJ6	EUDAMED	Class I	Active
Neoprene heel sleeves	B079VRVSM1	EUDAMED	Class I	Active
Pro 11 Wellbeing Hydro-Tech Sports Orthotic Insoles	B01BC80AZS	EUDAMED	Class I	Active

Pro 11 Wellbeing Limited

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