Question 1

What types of medical devices does Enoch’s Manufacturing Inc produce?

Accepted Answer

Enoch’s Manufacturing Inc specializes in electrically powered examination and treatment chairs, as well as line-powered examination and treatment tables. These devices are designed for clinical use in general medical settings, such as examining rooms, to assist with patient positioning and procedural comfort. The portfolio includes modular furniture solutions tailored for routine clinical assessments and minor treatments.

Question 2

Where is Enoch’s Manufacturing Inc based?

Accepted Answer

Enoch’s Manufacturing Inc is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the US, which governs the design, manufacturing, and distribution of its medical devices.

Question 3

Which regulatory registries list Enoch’s Manufacturing Inc’s devices?

Accepted Answer

Enoch’s Manufacturing Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with US regulatory requirements, allowing healthcare providers and authorities to identify and track the devices in the market.

Question 4

How are Enoch’s Manufacturing Inc’s devices classified under US regulations?

Accepted Answer

Enoch’s Manufacturing Inc’s devices fall under Class I regulatory classification in the US. This classification is assigned to low-risk medical devices, which typically require less stringent regulatory oversight compared to higher-risk categories. The classification reflects the minimal risk associated with these examination and treatment furniture items.

Device	Model / Reference	Registries	Class	Status
ENOCHS Examining Room Furniture	2250	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4250	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4520-05	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4520-00	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4520-01	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4520-04	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	6220	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4520-02	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4510	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4550-05	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	6210	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4200	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4520-03	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4550-02	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4520-06	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4550-03	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4550-01	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4550-00	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4550-06	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4520-07	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4550-07	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	4550-04	FDA UDI	Class I	Active
ENOCHS Examining Room Furniture	6250	FDA UDI	Class I	Active

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