FDA.reportPublic FDA data

Slimspec

Primary DI
07290016498615
Brand
Slimspec
Company
MEDISPEC LTD.
Model
LX-5-A999b
Device description
Radial wave therapy
Published
2023-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07290016498615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016498615072900164986157290016498615

GMDN Terms#

Term, Definition table
TermDefinition
Pressure-wave skin contouring systemAn assembly of devices using extracorporeal pulse activation technology (EPAT) and designed for acoustic wave treatment (AWT) intended primarily to reduce the appearance of cellulite through mobilization of free fatty acids and oxidative agents in tissue. It typically consists of a control unit that produces pneumatically-generated and/or electrically-generated pressure waves at selected impulse frequencies by means of one or more hand-held, skin-surface applicators. The system may also be used to treat the skin, e.g., by smoothing wrinkles, tightening muscle/connective tissue, and/or improving lymphatic drainage; it may also be used to treat minor muscle pain.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600300909
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
07290016498455LithospecLS-6-A999b2023-06-08
07290016498110Omnispec ED1000OR-5-A999k2023-06-07
07290016498752RadialspecLS-5-A999b2023-06-07
07290016498257Econolith E2000SW-7-A9992018-08-08
07290016498301Econolith E3000SW-6-A999b2018-08-08
07290016498318Econolith E3000SW-6-A999d2018-08-08
07290016498356Econolith EM1000SW-8A999b2018-08-08
07290016498363Econolith EM1000SW-8-A999d2018-08-08
07290016498370Econolith EM1000SW-8-A999m2018-08-08
07290016498387Econolith EM1000SW-8-A999q2018-08-08
07290016498394Econolith EM1000SW-8-A999r2018-08-08
07290016498417OrthospecOR-3-A999u2017-06-22

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