PCC · Class II · 21 CFR 882.5891

FDA Product Code PCC: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.

Leading manufacturers include Nu Eyne Co., Ltd., Cefaly Technology and Neurolief , Ltd..

18
Total
17
Cleared
181d
Avg days
2014
Since
Declining activity - 3 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 125d recently vs 192d historically

FDA 510(k) Cleared Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Devices (Product Code PCC)

18 devices
1–18 of 18
Cleared Apr 16, 2026
Enso for Migraine
K254216
Hinge Health, Inc.
Neurology · 108d
Cleared Nov 06, 2024
ELEXIR 2.0 (ALLIVE3)
K242719
Nu Eyne Co., Ltd.
Neurology · 57d
Cleared Jul 18, 2024
CEFALY Connected - OTC, CEFALY Connected - Rx
K234029
Cefaly Technology
Neurology · 211d
Cleared Jun 11, 2024
DOOPANG
K232749
Ybrain, Inc.
Neurology · 277d
Cleared Jun 03, 2024
Milieve (YPS-301BD)
K233751
Soterix Medical, Inc.
Neurology · 194d
Cleared Feb 26, 2024
TENS device-HeadaTerm 2 (Model: YF-HT2)
K230782
Wat Medical Technology, Inc.
Neurology · 341d
Cleared Dec 13, 2022
Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx
K212071
Cefaly Technology
Neurology · 529d
Cleared Aug 02, 2021
Relivion
K212106
Neurolief , Ltd.
Neurology · 27d
Cleared Jul 30, 2021
Elexir
K211380
Nu Eyne Co., Ltd.
Neurology · 87d
Cleared Jun 17, 2021
Migraine Tens Digital Pain Reliever
K210364
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 129d
Cleared Feb 16, 2021
Relivion
K203419
Neurolief , Ltd.
Neurology · 89d
Cleared Sep 29, 2020
Cefaly Dual
K201895
Cefaly Technology
Neurology · 83d
Cleared Dec 06, 2019
ALLIVE
K192773
Nu Eyne Co., Ltd.
Neurology · 67d
Cleared Sep 13, 2018
TENS device-HeadaTerm, eEspress
K172450
Wat Medical Technology (Ningbo) Co., Ltd.
Neurology · 395d

About Product Code PCC - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code PCC since 2014, with 17 receiving FDA clearance (average review time: 181 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - PCC Product Code

Recent submissions under PCC have taken an average of 125 days to reach a decision - down from 192 days historically, suggesting improved FDA processing for this classification.

PCC devices are reviewed by the Neurology panel. Browse all Neurology devices →