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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 charging case ensures the charging of the actiTENS Electric impulse generator. FDA UDI
Model / Reference
Charging case FDA UDI
Description
The charging case ensures the charging of the actiTENS Electric impulse generator. FDA UDI

Identifiers

Catalog Number
SBM1AF110 FDA UDI
Primary DI / UDI-DI
B786SBM1AF1100 FDA UDI
510(k) Number
K202159 FDA UDI
FDA Product Code
GZJ FDA UDI
IPF FDA UDI
NGX FDA UDI
NYN 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
890.5850 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: 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 2596f0ee-9712-432f-89af-1b7582c76ee0 35 fields · synced May 30, 2026