Question 1

What types of medical devices does Champion Manufacturing Inc. produce?

Accepted Answer

Champion Manufacturing Inc. specializes in general-purpose stools and chairs. These devices are designed for use in clinical, laboratory, and patient care settings, providing seating support for patients, healthcare staff, or medical equipment. The focus is on versatile, functional seating solutions tailored for medical environments.

Question 2

Where is Champion Manufacturing Inc. based, and where are its devices manufactured?

Accepted Answer

Champion Manufacturing Inc. is based in the United States. The company’s devices, including stools and chairs, are manufactured domestically in the US. This aligns with the company’s focus on producing medical-grade seating solutions for clinical and patient care applications.

Question 3

How are Champion Manufacturing Inc.’s devices classified by regulatory authorities?

Accepted Answer

Champion Manufacturing Inc.’s devices fall under Class I classification, which is the lowest risk category for medical devices. This classification is typically assigned to products posing minimal risk to patients and users, such as general-purpose stools and chairs. Class I devices often require less stringent regulatory oversight but must still meet safety and performance standards.

Question 4

Are Champion Manufacturing Inc.’s devices listed in any regulatory registries?

Accepted Answer

Yes, Champion Manufacturing Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in regulatory and market surveillance processes. This listing supports compliance and identification for devices like stools and chairs used in medical settings.

Device	Model / Reference	Registries	Class	Status
Champion	Alo Treatment Medical Recliner Power XL	FDA UDI	Class I	Active
Champion	59 Series Medical Recliner	FDA UDI	Class I	Active
Champion	Alo Recovery Medical Recliner	FDA UDI	Class I	Active
Champion	56 Series Medical Recliner	FDA UDI	Class I	Active
Champion	Concord Series Recliner	FDA UDI	Class I	Active
Champion	Passage Medical Recliner	FDA UDI	Class I	Active
Champion	Alo Recovery Medical Recliner Power	FDA UDI	Class I	Active
Champion	54P Series Medical Recliner	FDA UDI	Class I	Active
Champion	85P Series Medical Recliner	FDA UDI	Class I	Active
Champion	Alo Recovery Medical Recliner Power	FDA UDI	Class I	Active
Champion	Unity Recliner 300 Series	FDA UDI	Class I	Active
Champion	86P Series Medical Recliner XL	FDA UDI	Class I	Active
Champion	59P Series Medical Relax Recliner	FDA UDI	Class I	Active
Champion	Ascent Medical Recliner Power XL	FDA UDI	Class I	Active
Champion	Alo Treatment Medical Recliner Power	FDA UDI	Class I	Active
Champion	Alo Treatment Medical Recliner XL	FDA UDI	Class I	Active
Champion	Alo Treatment Medical Recliner Power XL	FDA UDI	Class I	Active
Champion	Ascent Medical Recliner	FDA UDI	Class I	Active
Champion	Unity Treatment Recliner Wide 31X Series	FDA UDI	Class I	Active
Champion	Ascent II Medical Recliner Power XL	FDA UDI	Class I	Active
Champion	Alo Recovery Medical Recliner XL	FDA UDI	Class I	Active
Champion	85 Series Medical Recliner	FDA UDI	Class I	Active
Champion	58P Series Medical Relax Recliner XL	FDA UDI	Class I	Active
Champion	Passage Medical Recliner	FDA UDI	Class I	Active
Champion	Unity Treatment Recliner 310 Series	FDA UDI	Class I	Active
Champion	Alo Recovery Medical Recliner Power XL	FDA UDI	Class I	Active
Champion	56P Series Medical Recliner XL	FDA UDI	Class I	Active
Champion	Ascent II Medical Recliner XL	FDA UDI	Class I	Active
Champion	Alo Treatment Medical Recliner	FDA UDI	Class I	Active
Champion	54 Series Medical Recliner	FDA UDI	Class I	Active
Champion	Alo Recovery Medical Recliner	FDA UDI	Class I	Active
Champion	89 Series Medical Relax Recliner	FDA UDI	Class I	Active
Champion	Ascent Medical Recliner XL	FDA UDI	Class I	Active
Champion	Alo Recovery Medical Recliner Power XL	FDA UDI	Class I	Active
Champion	Classic 547	FDA UDI	Class I	Active
Champion	Ascent II Medical Recliner	FDA UDI	Class I	Active
Champion	Ascent II Medical Recliner Power	FDA UDI	Class I	Active
Champion	Alo Recovery Medical Recliner XL	FDA UDI	Class I	Active
Champion	Continuum Recliner	FDA UDI	Class I	Active
Champion	Unity Clinical Recliner 31X Series	FDA UDI	Class I	Active
Champion	58 Series Medical Recliner	FDA UDI	Class I	Active
Champion	Alo Medical Recliner	FDA UDI	Class I	Active
Champion	86 Series Medical Recliner XL	FDA UDI	Class I	Active
Champion	89P Series Medical Relax Recliner	FDA UDI	Class I	Active
Champion	Alo Treatment Medical Recliner Power	FDA UDI	Class I	Active
Champion	Unity Clinical Recliner 310 Series	FDA UDI	Class I	Active
Champion	Ascent Medical Recliner Power	FDA UDI	Class I	Active

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