Evolve System

FDA UDI

Class II (US FDA UDI)

by Inmode MD , Ltd.

Identity

Trade Name: Evolve System FDA UDI
Generic Name: Multi-modality skin surface treatment system FDA UDI
Device Name: The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions. The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The T3 Applicator in EMS mode is intended for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate post surgical stimulation of calf muscle to prevent venous thrombosis The T3 Applicator in TENS mode is intended for: - Symptomatic relief and management of chronic, intractable pain - Post-surgical acute pain - Post-trauma acute pain The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially. FDA UDI
Model / Reference: AG608081A FDA UDI
Description: The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions. The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The T3 Applicator in EMS mode is intended for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate post surgical stimulation of calf muscle to prevent venous thrombosis The T3 Applicator in TENS mode is intended for: - Symptomatic relief and management of chronic, intractable pain - Post-surgical acute pain - Post-trauma acute pain The RF treatment mode and EMS/TENS mode should not be used in combination or sequentially. FDA UDI

Identifiers

Catalog Number: AG608081A FDA UDI
Primary DI / UDI-DI: 07290016633498 FDA UDI
510(k) Number: K210877 FDA UDI
FDA Product Code: IPF FDA UDI
GZJ FDA UDI
PBX FDA UDI
GMDN Term: Multi-modality skin surface treatment system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5850 FDA UDI
882.5890 FDA UDI
878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-modality skin surface treatment system

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Inmode MD , Ltd.

Sources (1)

FDA UDI 06b94eb6-5637-4e3e-bea2-468c002f6308 37 fields · synced May 31, 2026