Question 1

What types of medical devices does Mp2g Diagnostic Corp manufacture?

Accepted Answer

Mp2g Diagnostic Corp specializes in mobility aids and assistive devices. Their product line includes foldable and non-foldable walkers, elbow and axillary crutches, manual wheelchairs (both standard and bariatric), single-base walking sticks, foldable walking frames, and bathing assistive devices like back rests and seats. These devices are designed to support independent movement and daily activities for users.

Question 2

Where is Mp2g Diagnostic Corp based?

Accepted Answer

Mp2g Diagnostic Corp is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing standards, and distribution networks, particularly when addressing inquiries about device availability or compliance with US regulatory requirements.

Question 3

Which regulatory registries list Mp2g Diagnostic Corp’s devices?

Accepted Answer

Mp2g Diagnostic Corp’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices for regulatory, safety, and market surveillance purposes, ensuring transparency and traceability of their products in the US market.

Question 4

How are Mp2g Diagnostic Corp’s devices classified under FDA regulations?

Accepted Answer

Mp2g Diagnostic Corp’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.

Device	Model / Reference	Registries	Class	Status
Gaesca	Gaesca Aluminium Foldable Rollator 8" PVC Castors (Red)	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Adjustable Shower Chair w/backrest	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Elbow Crutches Standard (Pair)	FDA UDI	Class I	Active
Gaesca	Gaesca Steel Rollator 18" (Red Color)	FDA UDI	Class I	Active
Gaesca	Gaesca Wheelchair for overweight people - removable foot rest 24" width	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Elbow Crutches Gray (Pair)	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Basic Crutches S	FDA UDI	Class I	Active
Gaesca	Gaesca Transportation Wheelchair 24" Width	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Walking Stick	FDA UDI	Class I	Active
Gaesca	Gaesca Steel Foldable Rollator 8" PVC Castor Wheels (Red)	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Basic Walker Foldable	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Quad Cane	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Elbow Crutches Blue (Pair)	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Basic Crutches L	FDA UDI	Class I	Active
Gaesca	Gaesca Standard Wheelchair armrest footrest removable 264lbs/120kgs	FDA UDI	Class I	Active
Gaesca	Gaesca Standard Wheelchair Armrest and Footrest removable 220lbs/100kgs	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Basic Crutches M	FDA UDI	Class I	Active
Keuz	KEUZ Alternating-Pressure Bed Mattress overlay system	FDA UDI	Class II	Active
Gaesca	Gaesca Aluminium Foldable Walker with Wheels	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Foldable Rollator 8" PVC Castors (Blue)	FDA UDI	Class I	Active
Gaesca	Gaesca Aluminium Elbow Crutches Black (Pair)	FDA UDI	Class I	Active
Gaesca	Gaesca Steel Foldable Rollator 8" PVC Castor Wheels (Blue)	FDA UDI	Class I	Active
Gaesca	Gaesca Standard Basic Portable Wheelchair 220 lbs/100 kgs weight capacity	FDA UDI	Class I	Active
Gaesca	Gaesca Transportation Wheelchair 22" Width	FDA UDI	Class I	Active

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