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Sign in to claim this brandWhat L P G SYSTEMS makes
L P G Systems manufactures hand-held electric massagers designed for targeted muscle relief and prone scooter boards used to assist patient mobility and positioning. The WELLBOX and HUBER devices are part of this portfolio, catering to clinical and homecare settings for patient comfort and rehabilitation support.
The company’s products are regulated under FDA’s Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. L P G Systems operates from the United States, adhering to applicable U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does L P G Systems manufacture?
L P G Systems produces two primary types of medical devices: hand-held electric massagers, which are designed for targeted muscle relief, and prone scooter boards, which assist patients with mobility and positioning. These devices are intended for use in clinical and homecare settings to support patient comfort and rehabilitation.
Where is L P G Systems based, and does its location affect its regulatory compliance?
L P G Systems is based in the United States. Since the company operates within the U.S., its devices must comply with FDA regulations, including classification under FDA’s Class I or Class II categories, and are required to be listed in the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries list L P G Systems’ devices, and why is this important?
L P G Systems’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is important because it provides transparent, traceable information about the devices, including their identification, classification, and regulatory status, which helps healthcare providers, regulators, and patients verify compliance and safety.
How are L P G Systems’ devices classified under FDA regulations, and what does that mean?
L P G Systems’ devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 394430433
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