FDA.reportPublic FDA data

stratosphere

Primary DI
04262384030004
Brand
stratosphere
Company
Saxony Beauty Technology GmbH
Model
24
Catalog number
TMSTR01
Device description
Massager for body sculpting and anti-cellulite procedures.
Published
2023-04-11
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
04262384030004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262384030004042623840300044262384030004

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height101Centimeter
Length50Centimeter
Width41Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-50 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+17028880889Dr777amb@gmail.com

Regulatory Flags#

DUNS number
313345439
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04262384030011stratosphereCelluShotTMSTRCS022023-04-11
04262384030028stratosphereSoloTMSTRSL032023-04-11
04262384030035stratosphereSmartTMSTRSM042023-04-11
04262384030042Dr. BlitzFaceTMDrBF012023-04-11
04262384030059Dr. BlitzSoloTMDrBS032023-04-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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