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	3001KL-AM	FDA UDI	Class I	Active
Health o meter professional	752KGWA	FDA UDI	Class I	Active
Health o meter professional	597KLWA	FDA UDI	Class I	Active
Health o meter Professional	599KL	FDA UDI	Class I	Active
Health o meter professional	2610KG-BT	FDA UDI	Class I	Active
Health o meter Professional	2210KG4-AM-C	FDA UDI	Class I	Active
Health o meter professional	3001KG-AMX	FDA UDI	Class I	Active
Health o meter Professional	402KL	FDA UDI	Class I	Active
Health o meter professional	3105KL-AM	FDA UDI	Class I	Active
Health o meter professional	402LB	FDA UDI	Class I	Active
Health o meter Professional	2210KG-AM-BT-C	FDA UDI	Class I	Active
Health o meter professional	400KLWHCW	FDA UDI	Class I	Active
Health o meter professional	349KLXFUT	FDA UDI	Class I	Active
Health o meter professional	2600KL-BT	FDA UDI	Class I	Active
Health o meter professional	844KL-C	FDA UDI	Class I	Active
Health o meter Professional	2210KL-AM-BT-C	FDA UDI	Class I	Active
Health o meter professional	895KLT	FDA UDI	Class I	Active
Health o meter Professional	1100KLHR-BT	FDA UDI	Class I	Active
Health o meter professional	3001KL-AM-BT	FDA UDI	Class I	Active
Health o meter professional	2650KG	FDA UDI	Class I	Active
Health o meter professional	599KLWA	FDA UDI	Class I	Active
Health o meter professional	600KG-BT	FDA UDI	Class I	Active
Health o meter professional	498KL-SC	FDA UDI	Class I	Active
Health o meter professional	2500CKL-BT	FDA UDI	Class I	Active
Health o meter professional	3001KG-AM	FDA UDI	Class I	Active
Health o meter Professional	142KL	FDA UDI	Class I	Active
Health o meter Professional	2210KL4-AM-C	FDA UDI	Class I	Active
Health o meter Professional	2000KL	FDA UDI	Class I	Active
Health o meter professional	2500KL-BT	FDA UDI	Class I	Active
Health o meter professional	522KLWA	FDA UDI	Class I	Active
Health o meter Professional	2210KG4-AM	FDA UDI	Class I	Active
Health o meter professional	3105KG-AM	FDA UDI	Class I	Active
Health o meter professional	499KLAD	FDA UDI	Class I	Active
Health o meter professional	499KGHR	FDA UDI	Class I	Active
Health o meter professional	2000KG-BT	FDA UDI	Class I	Active
Health o meter Professional	499KL	FDA UDI	Class I	Active
Health o meter professional	3001KL-AM-BT-EHR	FDA UDI	Class I	Active
Health o meter professional	5900	FDA UDI	Class I	Active
Health o meter Professional	349KLX	FDA UDI	Class I	Active
Health o meter professional	1110KL	FDA UDI	Class I	Active
Health o meter professional	752KL-BT	FDA UDI	Class I	Active
Health o meter professional	402KLCW	FDA UDI	Class I	Active
Health o meter professional	499KGAD	FDA UDI	Class I	Active
Health o meter Professional	522KL	FDA UDI	Class I	Active
Health o meter professional	498KG	FDA UDI	Class I	Active
Health o meter professional	3001KG-AMHR-BT	FDA UDI	Class I	Active
Health o meter professional	1110KG-BT	FDA UDI	Class I	Active
Health o meter Professional	500KL	FDA UDI	Class I	Active
Health o meter Professional	1522KLHW	FDA UDI	Class I	Active
Health o meter Professional	2000KG	FDA UDI	Class I	Active

PELSTAR LLC

What PELSTAR LLC makes

Frequently asked questions

Information

Catalogue (247)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Recalls (1)