FDA.reportPublic FDA data

Plus Handpiece

Primary DI
08034108512679
Brand
Plus Handpiece
Company
DEKA M.E.L.A. SRL
Model
E098H1
Device description
"The Plus Handpiece is indicated for temporary increase in local blood circulation, and activation of connective tissue.The Plus Handpiece (Type B) is capable of emitting a pulsed ""air massage"" on the area to be treated.The Plus Handpiece is also equipped with an Off/On button."
Published
2025-10-22
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
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08034108512679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034108512679080341085126798034108512679

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Regulatory Flags#

DUNS number
629381096
Device count
1
Premarket exempt
true
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
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
08057017760771DEKA PHYSIQ 360 EMS ModuleF53701F537012023-10-12

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