FDA.reportPublic FDA data

Silk'n

Primary DI
07290016627688
Brand
Silk'n
Company
HOME SKINOVATIONS LTD
Model
Lipo Duo
Catalog number
7290016627664
Device description
2 Bricks with accessories
Published
2018-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
07290016627688Direct MarkingGS10
27290016627668PackageGS11In Commercial Distribution
27290016627675PackageGS11In Commercial Distribution
27290016627682PackageGS11In Commercial Distribution
37290016627665PackageGS14In Commercial Distribution
37290016627672PackageGS14In Commercial Distribution
37290016627689PackageGS14In Commercial Distribution
17290016627661PrimaryGS10
17290016627678PrimaryGS10
17290016627685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016627688072900166276887290016627688
2729001662766827290016627668
2729001662767527290016627675
2729001662768227290016627682
3729001662766537290016627665
3729001662767237290016627672
3729001662768937290016627689
1729001662766117290016627661
1729001662767817290016627678
1729001662768517290016627685

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit 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. 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 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-367-4556contact@silkn.com

Regulatory Flags#

DUNS number
514891048
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10074590550860RemingtonIPL350000745905508632017-07-12
10075020040319PHILIPSLumea Comfort SC19810750200403122016-08-15
10866057000311SISLOYSupreme8660570003142017-06-18
17290015418468Silk'nFlash & Go Compact72900154184612016-08-15
17290015418512Silk'nGlide 150K Brazil72900154185152017-04-26
17290015418864Silk'nFlash & Go Express 72900154188672016-08-15
17290015763858Silk'nTitan72900157638512017-05-09
17290015764039Silk'nGlide Express Brazil 72900157640322017-04-26
17290015764527Silk'nBellaGlide72900157645202016-08-15
17290015764633Silk'nFaceFX 36072900157646362018-12-19
17290015764640Silk'nJewel72900157646432016-08-15
17290016627081Silk'nBellaFlash Pro72900166270842018-01-25
17290016627128Silk'nFlash & Go Pro72900166271212018-01-25
17290016627388Silk'nBellaGlide72900166273812017-07-12
17290016627852Silk'nFlash & Go LUXX72900166278552018-01-25
17290106259215PREMIER (AVOLOGI)Renelif72901062592182017-01-26
17290112450552Silk'nFlash & Go LUXX Mini-Spa72901124505552020-06-17
18712856055712Silk'nGlide87128560557152017-07-12
27290112450559Silk'nFlash & Go LUXX Mini-Spa72901124505552020-06-17
17290112452013Silk'n BellaVisage Hybrid72901124520162021-08-08

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