Roovjoy

FDA UDI

Class II (US FDA UDI)

by Shenzhen roundwhale technology co. LTD.

Identity

Trade Name: ROOVJOY FDA UDI
Generic Name: Transcutaneous electrical stimulation probe FDA UDI
Model / Reference: R-C101K FDA UDI

Identifiers

Primary DI / UDI-DI: 06971763600582 FDA UDI
FDA Product Code: NUH FDA UDI
GZJ FDA UDI
IPF FDA UDI
NGX FDA UDI
GMDN Term: Transcutaneous electrical stimulation probe 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

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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 Transcutaneous electrical stimulation probe

Roovjoy by Shenzhen roundwhale technology co. LTD. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Shenzhen roundwhale technology co. LTD.

Sources (1)

FDA UDI c7e02730-3236-4142-a950-d4bb127e476f 32 fields · synced May 30, 2026