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FDA 510(k)

NeoWave Pain Relief and Recovery System, Model# T16-2020

K-Number: K202693 · 2021-03-05

ApplicantEva Medtec, Inc.
Decision Date2021-03-05
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NeoWave Pain Relief and Recovery System, Model# T16-2020 is a medical device manufactured by Eva Medtec, Inc.. It received FDA 510(k) clearance on 2021-03-05 under approval number K202693. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeoWave Pain Relief and Recovery System, Model# T16-2020?

NeoWave Pain Relief and Recovery System, Model# T16-2020 is a medical device that received FDA 510(k) clearance on 2021-03-05. It is manufactured by Eva Medtec, Inc.. The 510(k) number is K202693.

When was NeoWave Pain Relief and Recovery System, Model# T16-2020 approved by the FDA?

NeoWave Pain Relief and Recovery System, Model# T16-2020 received FDA 510(k) clearance on 2021-03-05, under approval number K202693.

What company makes NeoWave Pain Relief and Recovery System, Model# T16-2020?

NeoWave Pain Relief and Recovery System, Model# T16-2020 is manufactured by Eva Medtec, Inc..

What is the FDA product code for NeoWave Pain Relief and Recovery System, Model# T16-2020?

The FDA product code for NeoWave Pain Relief and Recovery System, Model# T16-2020 is IRP.

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Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023) PMID: 29082710 [How to adapt to the requirements of "clinical value-oriented drug innovation" for pharmaceutical research in application process of new traditional Chinese medicine]. Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica (2017)

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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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