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Rst-Sanexas Pt

FDA UDI

Class II (US FDA UDI)

by Rst-Sanexas

Identity

Trade Name
RST-SANEXAS PT FDA UDI
Generic Name
Transcranial electrical stimulation system, pulsed-current FDA UDI
Model / Reference
RST-SANEXAS PT FDA UDI

Identifiers

Primary DI / UDI-DI
00860000214049 FDA UDI
510(k) Number
K022433 FDA UDI
FDA Product Code
IPF FDA UDI
LIH FDA UDI
GZJ FDA UDI
GMDN Term
Transcranial electrical stimulation system, pulsed-current FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
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

Yes

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

No

FDA UDI

Category: Transcranial electrical stimulation system, pulsed-current

Rst-Sanexas Pt by Rst-Sanexas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K022433 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rst-Sanexas

Sources (1)

  • FDA UDI b3d89625-0b6c-4ef3-985f-fb7d3c0da133 34 fields · synced Jun 1, 2026