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HeadaTerm

FDA UDI

Class II (US FDA UDI)

by Wat Medical Technology, Inc.

Identity

Trade Name
HeadaTerm FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older. FDA UDI
Model / Reference
YF-HT2 FDA UDI
Description
The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older. FDA UDI

Identifiers

Primary DI / UDI-DI
06971760280138 FDA UDI
510(k) Number
K230782 FDA UDI
FDA Product Code
PCC FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5891 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

HeadaTerm by Wat Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wat Medical Technology, Inc.

Sources (1)

  • FDA UDI 90ff7509-1014-4fd3-8a3c-aed5a0496a4b 34 fields · synced Jun 8, 2026