Question 1

What types of medical devices does Specialty Health Products, Inc. manufacture?

Accepted Answer

Specialty Health Products, Inc. designs and manufactures medical devices for specific clinical applications. Their portfolio includes modified infusion sets, such as the LIFTLOC Safety Infusion Set, which are used for controlled fluid administration in medical procedures. They also produce colonic irrigation systems, like the Hydro-San Colonic Irrigation System, intended for gastrointestinal procedures. These devices are tailored to meet precise medical needs while adhering to regulatory standards.

Question 2

Where is Specialty Health Products, Inc. based?

Accepted Answer

Specialty Health Products, Inc. is headquartered in the United States. While the exact location isn’t specified, the company operates within the U.S. regulatory framework, which governs the design, manufacturing, and distribution of its medical devices.

Question 3

Which regulatory registries list the devices made by Specialty Health Products, Inc.?

Accepted Answer

The devices produced by Specialty Health Products, Inc. are listed in the FDA’s 510(k) database. This registry reflects devices that have undergone the 510(k) clearance process, demonstrating they meet the FDA’s requirements for authorised commercial distribution in the United States. Listing in this database is a key indicator of regulatory compliance for Class II devices.

Question 4

How are the devices manufactured by Specialty Health Products, Inc. classified under FDA regulations?

Accepted Answer

The devices manufactured by Specialty Health Products, Inc. fall under the FDA’s Class II classification. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. Class II devices typically require a 510(k) premarket notification submission to demonstrate substantial equivalence to a legally marketed predicate device.

Device	Model / Reference	Registries	Class	Status
Acu-Flow Temporary Matrix Material	MX261	FDA UDI	Class II	Active
ACU-flow PUTTY BASE + CATALYST KIT	PK901	FDA UDI	Class II	Active
ACU-flow HEAVY BODY	HB701	FDA UDI	Class II	Active
ACU-flow BITE REGISTRATION	BR801	FDA UDI	Class II	Active
ACU-flow LIGHT BODY PLUS	LB601	FDA UDI	Class II	Active
Acu-Flow Temporary Matrix Material	MX261	FDA UDI	Class II	Active
Light Body - Regular Flow	LIGHTBODYREGLBR501	FDA UDI	Class II	Active
ACU-flow THIXOTROPIC SILICONE MATERIAL	SR230	FDA UDI	Class II	Active
Best-Bite Bite Registration	BR805	FDA UDI	Class II	Active
ACU-flow RIGID-TRAY	RB401	FDA UDI	Class II	Active
Balance-Bite Bite Registration	BR812	FDA UDI	Class II	Active
ACU-flow MEDIUM BODY	MB301	FDA UDI	Class II	Active
Safety Cradle	K962149	FDA 510(k)	Class II	Active
Secureloc; Advancintroducer	K050023	FDA 510(k)	Class II	Active
Liftloc Safety Infusion Set	K013394	FDA 510(k)	Class II	Active
Extresafe Phlebotomy	K964042	FDA 510(k)	Class II	Active
Modification To: Liftloc Saftey Infusion Set	K042234	FDA 510(k)	Class II	Active
Hydro-San Colonic Irrigation System	K891585	FDA 510(k)	Class II	Active

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