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FDA 510(k)

Medline DeNovo 4Pro Electrical Stimulation Device

K-Number: K201290 · 2020-09-21

ApplicantMedline Industries, Inc.
Decision Date2020-09-21
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Medline DeNovo 4Pro Electrical Stimulation Device is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2020-09-21 under approval number K201290. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline DeNovo 4Pro Electrical Stimulation Device?

Medline DeNovo 4Pro Electrical Stimulation Device is a medical device that received FDA 510(k) clearance on 2020-09-21. It is manufactured by Medline Industries, Inc.. The 510(k) number is K201290.

When was Medline DeNovo 4Pro Electrical Stimulation Device approved by the FDA?

Medline DeNovo 4Pro Electrical Stimulation Device received FDA 510(k) clearance on 2020-09-21, under approval number K201290.

What company makes Medline DeNovo 4Pro Electrical Stimulation Device?

Medline DeNovo 4Pro Electrical Stimulation Device is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline DeNovo 4Pro Electrical Stimulation Device?

The FDA product code for Medline DeNovo 4Pro Electrical Stimulation Device is IPF.

Related Clinical Trials

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Related PubMed Literature

PMID: 41858417 AI-Driven Medical Device Risk Management: A New Paradigm Integrating Large Language Models and Prompt Engineering for Standard-Risk Knowledge Graph Construction and Application. Risk management and healthcare policy (2026) PMID: 40549731 Assessment of digital therapeutics in decentralized clinical trials: A scoping review. PLOS digital health (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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