510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PCCClass II

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

21 CFR 882.5891 / Neurology
FDA source (opens on fda.gov)

PCC is the FDA product code for Stimulator, Nerve, Electrical, Transcutaneous, For Migraine, a class II device type, regulated under 21 CFR 882.5891. FDA's definition for this code reads: "Used to apply an electrical current to a patient's cranium through electrodes placed on the skin". As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PCC
Device name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
FDA definition
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
Regulation
21 CFR 882.5891
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
18
Ingested recalls
0

Clearances, product code PCC

By decision year
18 clearances under product code PCC with a decision year between 2014 and 2026, 2024 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code PCC by decision year
YearClearances
20141
20161
20172
20181
20191
20201
20214
20221
20245
20261

Applicants with the most clearances

Product code PCC
Applicants holding the most 510(k) clearances under product code PCC
ApplicantClearances
Cefaly Technology6
NU Eyne Co., Ltd.3
NEUROLIEF Inc.2
Hinge Health Inc.1
Shenzhen Dongdixin Technology Co., Ltd.1
Soterix Medical,Inc.1
Stx-Med Sprl1
Wat Medical Technology (Ningbo) Co., Ltd.1
Wat Medical Technology Inc.1
Ybrain Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code