FDA.reportPublic FDA data

DEKA SIMON

Primary DI
08057017760696
Brand
DEKA SIMON
Company
DEKA M.E.L.A. SRL
Model
M134B1
Catalog number
M134B1
Device description
The DEKA SIMON is a device provided with 4 handpieces by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) technology for various medical application.
Published
2023-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPFStimulator, Muscle, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057017760696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057017760696080570177606968057017760696

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal1060 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
629381096
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034108513270ONDA PROM116V1M116V12025-11-17
08034108512877TOROM136E1M136E12026-03-11
08034108513317DEKA LUXEA PLUSM117B1117B12025-12-16
08034108512679Plus HandpieceE098H12025-10-22
08034108513263body ESTIQM116H1M116H12025-09-26
08034108513218OLOM141A1M141A12025-08-27
08034108512426ERISE Laser HandpieceE262B12023-06-16
08057017760689DEKA PHYSIQ 360M134A1M134A12023-10-11
08034108512419BioStimul HandpieceN378C12023-06-16
08034108512464PRISMAM135A12024-09-17
08034108512891MOTUS PROM130N12025-02-04
08034108512907MOTUS PRO AXM130P12025-02-04
08034108512495DEKA LILYM135B12024-09-17
08034108512730PRISMA EMS MODULEF552012024-09-17
08034108512709DEKA SMARTXIDE PROM079BI1M079R12024-04-09
08034108512808SMARTXIDE TETRA PROM118G12024-04-08
08034108512846Scar 3 PROF540A12024-04-04
08034108512655Elite iQ PROM122K1M122K12024-03-13
08034108512525AGAIN PROM126AA12023-10-31
08034108512532SYMPHONYM126AB12023-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712726417NourishnestHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-29
08032625829843NerveOTXDOMINO SRLIPF2026-07-28
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-03
08809851470145WavefacialWEERO Co., Ltd.IPF2026-06-22
G345SL2000CIONICCionic, Inc.IPF2026-06-04
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
04048223122235Stim2GoPajunk GmbH MedizintechnologieIPF2026-05-21
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
00816864021682accufitMETTLER ELECTRONICS CORP.IPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21