TenStim

FDA UDI

Class II (US FDA UDI)

by Hi-Dow International Incorporated

Identity

Trade Name: TenStim FDA UDI
Generic Name: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name: TenStim BLACK SILVER FDA UDI
Model / Reference: JQ-5C-R FDA UDI
Description: TenStim BLACK SILVER FDA UDI

Identifiers

Primary DI / UDI-DI: 00851640007375 FDA UDI
510(k) Number: K102598 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Transcutaneous electrical stimulation electrode, single-use Physical therapy transcutaneous neuromuscular electrical stimulation system Analgesic transcutaneous electrical nerve stimulation system Transcutaneous electrical stimulation lead

TenStim by Hi-Dow International Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Hi-Dow International Incorporated

Sources (1)

FDA UDI 66bfe6f1-af67-4819-8ca2-76ae148358e8 34 fields · synced May 30, 2026