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	386S01	FDA UDI	Class I	Active
Health o meter Professional	2900KL-AM-BT-C	FDA UDI	Class I	Active
Health o meter professional	2600KGWA	FDA UDI	Class I	Active
Health o meter professional	594KL-C	FDA UDI	Class I	Active
Health o meter Professional	142KG	FDA UDI	Class I	Active
Health o meter professional	522KG	FDA UDI	Class I	Active
Health o meter Professional	1100KL-EHR	FDA UDI	Class I	Active
Health o meter Professional	2900KG-AM-BT-C	FDA UDI	Class I	Active
Health o meter Professional	549KL	FDA UDI	Class I	Active
Health o meter Professional	1100KLHR	FDA UDI	Class I	Active
Health o meter professional	3001KL-AMUA	FDA UDI	Class I	Active
Health o meter professional	752KG-BT	FDA UDI	Class I	Active
Health o meter professional	752KG	FDA UDI	Class I	Active
Health o meter professional	894KL	FDA UDI	Class I	Active
Health o meter Professional	2101KL	FDA UDI	Class I	Active
Health o meter professional	523KL	FDA UDI	Class I	Active
Health o meter professional	2400KG-BT	FDA UDI	Class I	Active
Health o meter professional	1110KL-BT	FDA UDI	Class I	Active
Health o meter professional	2610KL-BT	FDA UDI	Class I	Active
Health o meter Professional	752KL	FDA UDI	Class I	Active
Health o meter professional	402LBWH	FDA UDI	Class I	Active
Health o meter professional	402KLWA	FDA UDI	Class I	Active
Health o meter Professional	2210KG4-AM-BT-C	FDA UDI	Class I	Active
Health o meter Professional	2210KL-AM-C	FDA UDI	Class I	Active
Health o meter professional	501KGAD	FDA UDI	Class I	Active
Health o meter professional	599KGHR	FDA UDI	Class I	Active
Health o meter professional	3001KG-AMUA-BT	FDA UDI	Class I	Active
Health o meter professional	402LBCERT	FDA UDI	Class I	Active
Health o meter professional	450KLHR	FDA UDI	Class I	Active
Health o meter professional	2500KG	FDA UDI	Class I	Active
Health o meter professional	2101KG-BT	FDA UDI	Class I	Active
Health o meter professional	386KGS-01	FDA UDI	Class I	Active
Health o meter professional	PTS-1000KL	FDA UDI	Class I	Active
Health o meter professional	880KG	FDA UDI	Class I	Active
Health o meter professional	501KLAD-BT	FDA UDI	Class I	Active
Health o meter professional	3001KG-AMHR	FDA UDI	Class I	Active
Health o meter Professional	1100KL-BT-EHR	FDA UDI	Class I	Active
Health o meter professional	402KLWHCW	FDA UDI	Class I	Active
Health o meter professional	599KG	FDA UDI	Class I	Active
Health o meter professional	2500KG-BT	FDA UDI	Class I	Active
Health o meter professional	501KL	FDA UDI	Class I	Active
Health o meter Professional	597KL	FDA UDI	Class I	Active
Health o meter Professional	3400KL	FDA UDI	Class I	Active
Health o meter professional	3001KL-AMX-BT	FDA UDI	Class I	Active
Health o meter Professional	810KLS	FDA UDI	Class I	Active
Health o meter Professional	2210KL4-AM	FDA UDI	Class I	Active
Health o meter professional	2101KLHR	FDA UDI	Class I	Active
Health o meter professional	2101KL-BT-EHR	FDA UDI	Class I	Active
Health o meter Professional	1522KL	FDA UDI	Class I	Active
Health o meter Professional	160KGWA	FDA UDI	Class I	Active

PELSTAR LLC

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