FDA 510(k)

First Relief v1

K-Number: K202940 · 2020-12-29

Decision Date2020-12-29

Product CodeQHH

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

First Relief v1 is the device name listed in this FDA 510(k) record. The listed applicant is Dyansys, Inc.. It received FDA 510(k) clearance on 2020-12-29 under 510(k) number K202940. The device is classified under product code QHH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the First Relief v1?

First Relief v1 is a medical device that received FDA 510(k) clearance on 2020-12-29. The listed applicant is Dyansys, Inc.. The 510(k) number is K202940.

When did First Relief v1 receive FDA 510(k) clearance?

First Relief v1 received FDA 510(k) clearance on 2020-12-29, under 510(k) number K202940.

Who is the listed applicant for First Relief v1?

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 v1?

The FDA product code for First Relief v1 is QHH.

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 K212859First Relief K211971Drug Relief v1

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Related Devices (Code: QHH)

K252024NeurAxis IB-Stim (01-1020)Neuraxis K250451NeurAxis IB-Stim (01-1020)Neuraxis K241533NeurAxis IB-Stim (01-1020)Neuraxis K230526TEA DeviceTranstimulation Research, 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.