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Sensus

FDA UDI

Class II (US FDA UDI)

by Neurometrix, Inc.

Identity

Trade Name
SENSUS FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
SENSUS System Kit, 1 Device (Includes 1 SE-S01 or QE-P01) FDA UDI
Model / Reference
SE-SK2 FDA UDI
Description
SENSUS System Kit, 1 Device (Includes 1 SE-S01 or QE-P01) FDA UDI

Identifiers

Primary DI / UDI-DI
00851221006285 FDA UDI
510(k) Number
K130919 FDA UDI
FDA Product Code
NUH FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Sensus by Neurometrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Cleared under the same submission

K130919 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurometrix, Inc.

Sources (1)

  • FDA UDI d8ac9e42-5426-4d66-881d-06ad9b4295f2 36 fields · synced May 30, 2026