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Prisma

by Deka M.E.L.A. SRL

Ref M135E1

Prisma (M135E1) is a medical device (EU MDR Class IIb; FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning; EMDN category phototherapy equipment) made by Deka M.E.L.A. SRL, registered in EUDAMED on 17 Feb 2026 (Basic UDI-DI 803410851M135E1MA), cleared under FDA 510(k) K233470 on 19 Dec 2023 and listed in FDA GUDID since 17 Sep 2024 (UDI-DI 08034108513294), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233470

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803410851M135E1MA Basic UDI-DI 08034108513294UDI-DIDate17 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08034108513294 UDI-DI Date17 Sep 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK233470 Date19 Dec 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803410851M135E1MA registered 17 Feb 2026 Active
  • FDA 510(k) K233470 decided 19 Dec 2023 Active
  • FDA GUDID UDI-DI 08034108513294 listed 17 Sep 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K233470
  2. Listed FDA GUDID 08034108513294
  3. Registered EUDAMED 803410851M135E1MA

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Prisma EUDAMED
Prisma Ems Module GUDID
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
M135E1 EUDAMED
F55201 GUDID
Primary DI / UDI-DI
08034108513294 EUDAMED
08034108512730 GUDID
Basic UDI-DI
803410851M135E1MA
510(k) Number
FDA product code
NGX
EMDN code
Z12040202 Phototherapy equipment
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
890.5850
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
M135E1
GUDID
F55201
Primary DI / UDI-DIEUDAMED
08034108513294
GUDID
08034108512730
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 08034108513294; FDA GUDID lists 08034108512730), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
IT-MF-000007389

Related devices

Category: Red-light phototherapy unit, professional

Similar devices in this category

Other devices filed under PHOTOTHERAPY EQUIPMENT.

Other devices from Deka M.E.L.A. SRL

See all devices from Deka M.E.L.A. SRL →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)