Question 1

What types of medical devices does Comfy Health Group Co., Ltd. manufacture?

Accepted Answer

Comfy Health Group Co., Ltd. specialises in static magnetic orthopaedic orthoses, which are devices designed to support and stabilise musculoskeletal structures. Their portfolio includes wrist/hand orthoses for upper limb support and multi-joint lower limb orthoses for lower body alignment and mobility. These devices are tailored for orthopaedic rehabilitation and functional support.

Question 2

Where is Comfy Health Group Co., Ltd. based?

Accepted Answer

Comfy Health Group Co., Ltd. is headquartered in the United States. This location is relevant for regulatory oversight and compliance with FDA requirements, particularly for devices listed in the UDI database.

Question 3

Which regulatory registries or databases list Comfy Health Group Co., Ltd.’s devices?

Accepted Answer

Comfy Health Group Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps ensure traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify device details.

Question 4

How are Comfy Health Group Co., Ltd.’s devices classified under FDA regulations?

Accepted Answer

Comfy Health Group Co., Ltd.’s devices are classified as Class I under FDA regulations. This classification applies to devices posing minimal risk to patients, such as certain orthoses, which typically require less stringent premarket review compared to higher-risk devices.

Device	Model / Reference	Registries	Class	Status
ComfyHealth	TE60	FDA UDI	Class I	Active
ComfyHealth	TE60	FDA UDI	Class I	Active
ComfyHealth	MS90	FDA UDI	Class I	Active
ComfyHealth	BP31	FDA UDI	Class I	Active
ComfyHealth	BS80	FDA UDI	Class I	Unknown
ComfyHealth	FE90	FDA UDI	Class I	Unknown
ComfyHealth	MS60	FDA UDI	Class I	Active
ComfyHealth	SE21	FDA UDI	Class I	Active
ComfyHealth	MS90	FDA UDI	Class I	Active
ComfyHealth	EE91	FDA UDI	Class I	Active
ComfyHealth	EE91	FDA UDI	Class I	Active
ComfyHealth	EE91	FDA UDI	Class I	Active
ComfyHealth	WP30	FDA UDI	Class I	Active
ComfyHealth	BP30	FDA UDI	Class I	Active
ComfyHealth	SE20	FDA UDI	Class I	Active
ComfyHealth	BP30	FDA UDI	Class I	Active
ComfyHealth	KP31	FDA UDI	Class I	Active
ComfyHealth	FE90	FDA UDI	Class I	Unknown
ComfyHealth	MS60	FDA UDI	Class I	Active
ComfyHealth	TE60	FDA UDI	Class I	Active
ComfyHealth	LE71	FDA UDI	Class I	Unknown
ComfyHealth	LE70	FDA UDI	Class I	Unknown
ComfyHealth	BS34	FDA UDI	Class I	Active
ComfyHealth	MS61	FDA UDI	Class I	Active
ComfyHealth	BP30	FDA UDI	Class I	Active
ComfyHealth	LE71	FDA UDI	Class I	Unknown
ComfyHealth	TP30	FDA UDI	Class I	Active
ComfyHealth	EP41	FDA UDI	Class I	Active
ComfyHealth	FE90	FDA UDI	Class I	Unknown
ComfyHealth	BS80	FDA UDI	Class I	Unknown
ComfyHealth	BP31	FDA UDI	Class I	Active
ComfyHealth	LE71	FDA UDI	Class I	Unknown
ComfyHealth	BP31	FDA UDI	Class I	Active
ComfyHealth	LE71	FDA UDI	Class I	Unknown
ComfyHealth	EP42	FDA UDI	Class I	Active

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