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510(k) K172450

TENS device-HeadaTerm, eEspress by Wat Medical Technology (Ningbo) Co., Ltd. — Product Code PCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2018
Date Received
August 14, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class
Class II
Regulation Number
882.5891
Review Panel
NE
Submission Type

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

Other clearances by Wat Medical Technology (Ningbo) Co., Ltd.

  • K172478 — TENS device-EmeTerm, CinvStop (April 19, 2018)

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