FDA.reportPublic FDA data

Plason

Primary DI
08800066190026
Brand
Plason
Company
SeoulinMedicare Co.,Ltd.
Model
SLM-9600
Published
2022-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
08800066190026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800066190026088000661900268800066190026

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
688896704
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
08800066110024N-DERMSLM-10012022-06-07
08800066100056SST Pro TipSST Pro Tip 0.32022-05-27
08800066100063SST Pro TipSST Pro Tip 0.42022-05-27
08800066100070SST Pro TipSST Pro Tip 0.52022-05-27
08800066100087SST Pro TipSST Pro Tip 0.62022-05-27
08800066100094SST Pro TipSST Pro Tip 0.82022-05-27
08800066100100SST Pro TipSST Pro Tip 1.02022-05-27
08800066110017SST ProSLM-10012022-05-27
08800066170035ProfacialSLM-7654E2022-05-27
08809540050023Plasma showerSLM-90022022-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
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