FDA 510(k)

First Relief

K-Number: K212859 · 2021-12-20

Decision Date2021-12-20

Product CodeNHI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

First Relief is the device name listed in this FDA 510(k) record. The listed applicant is Dyansys, Inc.. It received FDA 510(k) clearance on 2021-12-20 under 510(k) number K212859. The device is classified under product code NHI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the First Relief?

First Relief is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is Dyansys, Inc.. The 510(k) number is K212859.

When did First Relief receive FDA 510(k) clearance?

First Relief received FDA 510(k) clearance on 2021-12-20, under 510(k) number K212859.

Who is the listed applicant for First Relief?

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

What is the FDA product code for First Relief?

The FDA product code for First Relief is NHI.

Other records listing Dyansys, Inc. as applicant

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.

K221425Primary Relief K221231Drug Relief v1 K220397ANSiStim-PP K213188Primary Relief K211971Drug Relief v1 K202940First Relief v1

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Related Devices (Code: NHI)

K223306SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.K221425Primary ReliefDyansys, Inc.K220397ANSiStim-PPDyansys, Inc.K213188Primary ReliefDyansys, Inc.K211801SPRINT PNS SystemSpr Therapeutics, Inc.K202660SPRINT PNS SystemSpr Therapeutics, Inc.

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.