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actiTENS

FDA UDI

Class II (US FDA UDI)

by Sublimed

Identity

Trade Name
actiTENS FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
The actiTENS electric impulse generator can be held on the patient's body thanks to a self-adhesive trip made of a silicone-based adhesive. The self-adhesive strip is intended to be placed on any part of the body but not on injured or irritated skin. The purpose of the self-adhesive strip is to maintain the actiTENS electric impulse generator near the part of the body which the patient wants to stimulate. FDA UDI
Model / Reference
actiTENS self-adhesive strips FDA UDI
Description
The actiTENS electric impulse generator can be held on the patient's body thanks to a self-adhesive trip made of a silicone-based adhesive. The self-adhesive strip is intended to be placed on any part of the body but not on injured or irritated skin. The purpose of the self-adhesive strip is to maintain the actiTENS electric impulse generator near the part of the body which the patient wants to stimulate. FDA UDI

Identifiers

Catalog Number
SBM1AB011 FDA UDI
Primary DI / UDI-DI
B786SBM1AB0110 FDA UDI
510(k) Number
K202159 FDA UDI
FDA Product Code
NGX FDA UDI
NYN FDA UDI
GZJ FDA UDI
IPF FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

actiTENS by Sublimed — 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

K202159 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sublimed

Sources (1)

  • FDA UDI 74a6e0cd-ed40-45a9-88dd-bf0e22165e30 36 fields · synced May 29, 2026