← Back to catalogue

neoGEN

FDA UDI

Class II (US FDA UDI)

by Rst-Sanexas

Identity

Trade Name
neoGEN FDA UDI
Generic Name
Physical therapy transcutaneous electrical stimulation system, line-powered FDA UDI
Model / Reference
neoGEN FDA UDI

Identifiers

Primary DI / UDI-DI
00860000214001 FDA UDI
510(k) Number
K022433 FDA UDI
FDA Product Code
IPF FDA UDI
LIH FDA UDI
GZJ FDA UDI
GMDN Term
Physical therapy transcutaneous electrical stimulation system, line-powered 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: Physical therapy transcutaneous electrical stimulation system, line-powered

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

Similar devices

Also classified as Physical therapy transcutaneous electrical stimulation system, line-powered.

Cleared under the same submission

K022433 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Rst-Sanexas

Sources (1)

  • FDA UDI bb210e4c-6392-4370-bf98-c9eb19d3e70d 34 fields · synced Jun 8, 2026