Prisma

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref M135E1

by Deka M.e.l.a. Srl

Identity

Trade Name: PRISMA EUDAMED
PRISMA EMS MODULE FDA UDI
Generic Name: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI
Device Name: PRISMA EUDAMED
The PRISMA EMS MODULE device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit. The delivery of the electrical energy is controlled by a footswitch. The PRISMA EMS MODULE is provided with an applicator to perform EMS (Electrical Muscle Stimulation). The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes. The Applicator is directly applied on the area to be treated and moved by the operator across the skin. FDA UDI
Model / Reference: M135E1 EUDAMED
F55201 FDA UDI
Description: The PRISMA EMS MODULE device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit. The delivery of the electrical energy is controlled by a footswitch. The PRISMA EMS MODULE is provided with an applicator to perform EMS (Electrical Muscle Stimulation). The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes. The Applicator is directly applied on the area to be treated and moved by the operator across the skin. FDA UDI

Identifiers

Primary DI / UDI-DI: 08034108513294 EUDAMED
08034108512730 FDA UDI
Basic UDI-DI: 803410851M135E1MA EUDAMED
510(k) Number: K233470 FDA UDI
FDA Product Code: NGX FDA UDI
EMDN Code: Z12040202 PHOTOTHERAPY EQUIPMENT EUDAMED
GMDN Term: Physical therapy transcutaneous neuromuscular electrical stimulation system FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 890.5850 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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: Red-light phototherapy unit, professional

Prisma by Deka M.e.l.a. Srl — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	803410851M135E1MA	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

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Manufacturer

Manufacturer: Deka M.e.l.a. Srl
EUDAMED SRN: IT-MF-000007389

Sources (2)

EUDAMED 73ef90d0-7eec-4194-95e8-306067581568 61 fields · synced Jul 9, 2026
FDA UDI 604d280c-320f-4426-b186-4a07bbbd987d 34 fields · synced May 24, 2026