Question 1

What types of medical devices does Sidmar Manufacturing, Inc. produce?

Accepted Answer

Sidmar Manufacturing, Inc. specializes in dry hydro-massage systems, which are designed for therapeutic and relaxation purposes. These devices are intended to provide hydro-massage therapy without the use of water, focusing on muscle relief and comfort.

Question 2

Where is Sidmar Manufacturing, Inc. based?

Accepted Answer

Sidmar Manufacturing, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution within the region.

Question 3

How are Sidmar Manufacturing’s devices classified under FDA regulations?

Accepted Answer

Sidmar Manufacturing’s dry hydro-massage systems, such as the ComfortWave and Massage Time Pro models, are classified as Class I devices under FDA regulations. This classification is typically assigned to devices posing minimal risk to users, requiring less stringent regulatory oversight.

Question 4

Are Sidmar Manufacturing’s devices listed in any regulatory databases?

Accepted Answer

Yes, Sidmar Manufacturing’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency in the medical device supply chain, helping healthcare providers and regulators identify and track specific devices.

Device	Model / Reference	Registries	Class	Status
ComfortWave	CW-S10-Burg	FDA UDI	Class I	Active
Massage Time Pro	MTPSBlue-Left	FDA UDI	Class I	Active
Massage Time Pro	MTPSGreen	FDA UDI	Class I	Active
ComfortWave	CW-S10-Teal	FDA UDI	Class I	Active
Massage Time Pro	MTPSTeal	FDA UDI	Class I	Active
ComfortWave	CW-S10-Navy	FDA UDI	Class I	Active
Massage Time Pro	MTPSCustom-Left	FDA UDI	Class I	Active
ComfortWave	CW-S10-Tan	FDA UDI	Class I	Active
Massage Time Pro	MTPSNavy-Left	FDA UDI	Class I	Active
Massage Time Pro	MTPSGreen-Left	FDA UDI	Class I	Active
Massage Time Pro	MTPSCustom	FDA UDI	Class I	Active
ComfortWave	CW-S10-Blue	FDA UDI	Class I	Active
Massage Time Pro	MTPSBrown-Left	FDA UDI	Class I	Active
Massage Time Pro	MTPSBlack-Left	FDA UDI	Class I	Active
ComfortWave	CW-S10-Custom	FDA UDI	Class I	Active
ComfortWave	CW-S10-Black	FDA UDI	Class I	Active
Massage Time Pro	MTPSBurg	FDA UDI	Class I	Active
Massage Time Pro	MTPSTan	FDA UDI	Class I	Active
Massage Time Pro	MTPSBrown	FDA UDI	Class I	Active
Massage Time Pro	MTPSBurg-Left	FDA UDI	Class I	Active
Massage Time Pro	MTPSTeal-Left	FDA UDI	Class I	Active
ComfortWave	CW-S10-Gray	FDA UDI	Class I	Active
Massage Time Pro	MTPSGray	FDA UDI	Class I	Active
ComfortWave	CW-S10-Green	FDA UDI	Class I	Active
Massage Time Pro	MTPSGray-Left	FDA UDI	Class I	Active
Massage Time Pro	MTPSBlack	FDA UDI	Class I	Active
ComfortWave	CW-S10-Brown	FDA UDI	Class I	Active
Massage Time Pro	MTPSBlue	FDA UDI	Class I	Active
Massage Time Pro	MTPSNavy	FDA UDI	Class I	Active
Massage Time Pro	MTPSTan-Left	FDA UDI	Class I	Active

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