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Core

FDA UDI

Class II (US FDA UDI)

by Hi-Dow International Inc.

Identity

Trade Name
Core FDA UDI
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name
Pain Remedy Plus Wireless TENS/EMS System FDA UDI
Model / Reference
HD-5N-F FDA UDI
Description
Pain Remedy Plus Wireless TENS/EMS System FDA UDI

Identifiers

Primary DI / UDI-DI
00782944027014 FDA UDI
510(k) Number
K163393 FDA UDI
FDA Product Code
NUH FDA UDI
NGX FDA UDI
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 FDA UDI
890.5850 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Core by Hi-Dow International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K163393 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hi-Dow International Inc.

Sources (1)

  • FDA UDI 77d31551-40f4-4a1e-bb05-cda9226f9ff2 35 fields · synced Jun 8, 2026