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Tone Applicator

FDA UDI

Class II (US FDA UDI)

by Inmode MD , Ltd.

Identity

Trade Name
Tone Applicator FDA UDI
Generic Name
Transcutaneous electrical stimulation probe FDA UDI
Device Name
Tone Applicator FDA UDI
Model / Reference
AG608499A FDA UDI
Description
Tone Applicator FDA UDI

Identifiers

Catalog Number
AG608499A FDA UDI
Primary DI / UDI-DI
07290016633566 FDA UDI
510(k) Number
K192249 FDA UDI
K201285 FDA UDI
FDA Product Code
GZL FDA UDI
IPF FDA UDI
GMDN Term
Transcutaneous electrical stimulation probe FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1330 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

Yes

FDA UDI

Category: Transcutaneous electrical stimulation probe

Tone Applicator by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous electrical stimulation probe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inmode MD , Ltd.

Sources (1)

  • FDA UDI 4367c549-55d1-4091-abf8-97d94433d5da 37 fields · synced May 30, 2026