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reajoy

FDA UDI

Class II (US FDA UDI)

by Top-Rank Health Care Co., Ltd.

Identity

Trade Name
reajoy FDA UDI
Generic Name
Transcranial electrical stimulation system, pulsed-current FDA UDI
Device Name
Transcutaneous Electrical Nerve Stimulator FDA UDI
Model / Reference
TOPTENS-01 FDA UDI
Description
Transcutaneous Electrical Nerve Stimulator FDA UDI

Identifiers

Primary DI / UDI-DI
06973602730719 FDA UDI
510(k) Number
K210223 FDA UDI
FDA Product Code
NUH FDA UDI
GMDN Term
Transcranial electrical stimulation system, pulsed-current FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Transcranial electrical stimulation system, pulsed-current

reajoy by Top-Rank Health Care Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcranial electrical stimulation system, pulsed-current.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Top-Rank Health Care Co., Ltd.

Sources (1)

  • FDA UDI 0d2821ae-4ed4-4110-bda3-a90b87d85d42 34 fields · synced May 30, 2026