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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
Device Name
TENS mode It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low back, joint, hip, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. FDA UDI
Model / Reference
R-T1 FDA UDI
Description
TENS mode It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low back, joint, hip, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. FDA UDI

Identifiers

Primary DI / UDI-DI
00840001701014 FDA UDI
510(k) Number
K180956 FDA UDI
FDA Product Code
NUH FDA UDI
GMDN Term
Transcutaneous electrical stimulation probe FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

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

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

Cleared under the same submission

K180956 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen roundwhale technology co. LTD.

Sources (1)

  • FDA UDI 067432f0-9216-4392-ae80-5c13d9873249 35 fields · synced May 31, 2026