Allive

FDA 510(k) K192773 · Nu Eyne Co., Ltd.

Substantially Equivalent

510(k) numberK192773

Submission

Device name
Allive
Applicant
Nu Eyne Co., Ltd.
Seoul, KR
Received
September 30, 2019
Decision date
December 6, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PCC – Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5891
Specialty
Neurology

Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.

Other 510(k)s with product code PCC

510(k)DeviceApplicantDecision
K254216Enso for MigrainePCC · Traditional Hinge Health, Inc.04/16/2026SE
K242719Elexir 2.0 (ALLIVE3)PCC · Traditional Nu Eyne Co., Ltd.11/06/2024SE
K234029CEFALY Connected - OTC, CEFALY Connected - RxPCC · Traditional Cefaly Technology07/18/2024SE
K232749DoopangPCC · Traditional Ybrain, Inc.06/11/2024SE
K233751Milieve (YPS-301BD)PCC · Traditional Soterix Medical, Inc.06/03/2024SE
K230782TENS device-HeadaTerm 2 (Model: YF-HT2)PCC · Traditional Wat Medical Technology, Inc.02/26/2024SE
K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual…PCC · Traditional Cefaly Technology12/13/2022SE
K212106RelivionPCC · Special Neurolief , Ltd.08/02/2021SE
K211380ElexirPCC · Traditional Nu Eyne Co., Ltd.07/30/2021SE
K210364Migraine Tens Digital Pain RelieverPCC · Traditional Shenzhen Dongdixin Technology Co., Ltd.06/17/2021SE

More from Shenzhen Dongdixin Technology Co., Ltd.

510(k)DeviceDecision
K243289Addnox (BPSPM1)QGL · Traditional 01/16/2025SE
K242719Elexir 2.0 (ALLIVE3)PCC · Traditional 11/06/2024SE
K213629SmileQGL · Traditional 02/12/2023SE
K211380ElexirPCC · Traditional 07/30/2021SE

Questions and answers

When was Allive cleared by the FDA?

Allive (K192773) received a 510(k) decision of Substantially Equivalent on December 6, 2019, 67 days after the submission was received.

What is the product code of K192773?

The FDA product code is PCC – Stimulator, Nerve, Electrical, Transcutaneous, For Migraine, a Class II (moderate risk) device regulated under 21 CFR 882.5891.