Question 1

What types of medical devices does Pelstar LLC manufacture?

Accepted Answer

Pelstar LLC specializes in scales and patient transfer aids used in clinical and healthcare settings. Their product line includes electronic and mechanical stand-on floor scales, wheelchair-accessible platform scales, infant scales, and chair scales, which provide precise weight measurements. They also produce patient transfer aids like sliding boards and sling scales to assist with safe patient handling. These devices are designed for use in hospitals, clinics, and other medical environments where accurate weighing and mobility support are critical.

Question 2

Where is Pelstar LLC based, and does that affect their regulatory compliance?

Accepted Answer

Pelstar LLC is based in the United States, which means their devices are subject to U.S. medical device regulations. Since all their products fall under Class I classification, they must comply with general controls and are required to list their devices in the FDA’s UDI (Unique Device Identification) database. This classification applies because these devices pose minimal risk and are typically exempt from premarket approval but still require adherence to manufacturing and labeling standards.

Question 3

Which regulatory registries or databases list Pelstar LLC’s devices?

Accepted Answer

Pelstar LLC’s devices are listed in the FDA’s UDI (Unique Device Identification) database, which is a central registry for tracking medical devices in the U.S. under the Unique Device Identifier system. This database helps ensure transparency and traceability of devices like their scales and patient transfer aids, which are classified as Class I and subject to general regulatory controls. Listing in this database is mandatory for compliance with U.S. medical device regulations.

Question 4

How are Pelstar LLC’s devices classified under U.S. regulations?

Accepted Answer

Pelstar LLC’s devices are classified as Class I under U.S. medical device regulations. This classification is assigned based on the risk level of the products—Class I devices are considered low-risk and generally pose minimal harm to users. As a result, they are subject to general controls (such as good manufacturing practices and labeling requirements) rather than strict premarket approval. The company’s scales and patient transfer aids fall into this category because they are intended for routine clinical use without significant risk to patients.

Device	Model / Reference	Registries	Class	Status
Health o meter Professional	1100KL-BT	FDA UDI	Class I	Active
Health o meter professional	402KG	FDA UDI	Class I	Active
Health o meter Professional	2400KL	FDA UDI	Class I	Active
Health o meter professional	2500KGWA	FDA UDI	Class I	Active
Health o meter Professional	2500KL	FDA UDI	Class I	Active
Health o meter professional	2400KL-BT	FDA UDI	Class I	Active
Health o meter professional	5430	FDA UDI	Class I	Active
Health o meter professional	597KGWA	FDA UDI	Class I	Active
Health o meter professional	501KL-BT	FDA UDI	Class I	Active
Health o meter Professional	2210KL-AMCT	FDA UDI	Class I	Active
Health o meter professional	2650KG-BT	FDA UDI	Class I	Active
Health o meter Professional	2650KL	FDA UDI	Class I	Active
Health o meter professional	2600KG	FDA UDI	Class I	Active
Health o meter Professional	2600KL	FDA UDI	Class I	Active
Health o meter Professional	553KL	FDA UDI	Class I	Active
Health o meter Professional	498KL	FDA UDI	Class I	Active
Health o meter Professional	2842KL	FDA UDI	Class I	Active
Health o meter professional	5500	FDA UDI	Class I	Active
Health o meter Professional	1524KL	FDA UDI	Class I	Active
Health o meter professional	3001KL-AMC	FDA UDI	Class I	Active
Health o meter Professional	2900KL-AM-C	FDA UDI	Class I	Active
Health o meter professional	445KL	FDA UDI	Class I	Active
Health o meter professional	500KLAD	FDA UDI	Class I	Active
Health o meter Professional	2900KG-AM-C	FDA UDI	Class I	Active
Health o meter professional	3001KL-AMHR	FDA UDI	Class I	Active
Health o meter professional	2600KG-BT	FDA UDI	Class I	Active
Health o meter professional	2700KG-BT	FDA UDI	Class I	Active
Health o meter professional	499KLHR	FDA UDI	Class I	Active
Health o meter professional	402KLSB	FDA UDI	Class I	Active
Health o meter professional	2000KL-BT	FDA UDI	Class I	Active
Health o meter professional	402KLHR	FDA UDI	Class I	Active
Health o meter professional	3105KL-AM-BT	FDA UDI	Class I	Active
Health o meter professional	500KLWA	FDA UDI	Class I	Active
Health o meter professional	402KG50	FDA UDI	Class I	Active
Health o meter professional	501KG-BT	FDA UDI	Class I	Active
Health o meter professional	894KLT	FDA UDI	Class I	Active
Health o meter professional	3001KL-AM-EHR	FDA UDI	Class I	Active
Health o meter Professional	2610KL	FDA UDI	Class I	Active
Health o meter Professional	800KL	FDA UDI	Class I	Active
Health o meter professional	2650KGWA	FDA UDI	Class I	Active
Health o meter Professional	2900KL-AM-BT	FDA UDI	Class I	Active
Health o meter Professional	160KG	FDA UDI	Class I	Active
Health o meter Professional	600KL	FDA UDI	Class I	Active
Health o meter professional	2500CKG	FDA UDI	Class I	Active
Health o meter professional	3001KG-AMBT	FDA UDI	Class I	Active
Health o meter professional	2650KL-BT	FDA UDI	Class I	Active
Health o meter professional	500KL-BT	FDA UDI	Class I	Active
Health o meter Professional	2210KL4-AM-BT-C	FDA UDI	Class I	Active
Health o meter Professional	100KG	FDA UDI	Class I	Active
Health o meter professional	2700KG	FDA UDI	Class I	Active

PELSTAR LLC

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