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FDA 510(k)

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

K-Number: K202693 · 2021-03-05

Decision Date2021-03-05
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NeoWave Pain Relief and Recovery System, Model# T16-2020 is the device name listed in this FDA 510(k) record. The listed applicant is Eva Medtec, Inc.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) 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. The listed applicant is Eva Medtec, Inc.. The 510(k) number is K202693.

When did NeoWave Pain Relief and Recovery System, Model# T16-2020 receive FDA 510(k) clearance?

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

Who is the listed applicant for NeoWave Pain Relief and Recovery System, Model# T16-2020?

The FDA 510(k) record lists Eva Medtec, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: IRP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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