FDA.reportPublic FDA data

KBL beautyShaper

Primary DI
04260489020180
Brand
KBL beautyShaper
Company
KBL GmbH
Model
T3/50-180-c
Device description
This product is an over-the-counter powered exerciser emitting very bright light.
Published
2020-12-10
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
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260489020180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260489020180042604890201804260489020180

GMDN Terms#

Term, Definition table
TermDefinition
Vibration platform exerciser, stationaryA non-mobile, mains electricity (AC-powered) device designed to generate vertical high-intensity vibrations intended to traverse the body [whole body vibration (WBV)] and cause involuntary muscle contractions to help strengthen/tone muscles and tendons, increase blood flow and joint range of motion, and provide body massage and other health benefits. It consists of a motorized platform/plate, typically with a pole with a digital display/handrails, upon which the user can stand, sit, lay, or apply a specific body part. It may include accessories for specific training (e.g., resistance) and may be used in the home and athletic/clinical settings for rehabilitation or weight loss applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341936227
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
04260489020425R11 Air R11-s-2848r1-1188i1 UP 122025-06-25
04260489020418KBL K11 Air (Loft)K11-s-2010A-552B UP 052024-05-15
04260489020401KBL K9S vitaSunK9S-v-52-9s-2s UP cpi 052024-03-07
04260489020357KBL K5 pureSunK5-p-38-3Hp-0 UP ep 052023-06-09
04260489020364KBL K5 extraSunK5-e-38-3HP-0 UP ep 052023-06-09
04260489020371KBL K5 hybridSunK5-h-38-3Hp-0 UP ep 052023-06-09
04260489020388KBL K9S extraSunK9S-e-52-9s-2s UP cpi 052023-06-09
04260489020395KBL K9S hybridSunK9S-h-52-9s-2s UP cpi 052023-06-09
04260489020289KBL K7 extraSunK7-e-46-4HP-2s UP cpi 052022-12-20
04260489020296KBL K7 pureSunK7-p-46-4Hp-2s UP ep 052022-12-20
04260489020302KBL K7 pureSunK7-p-46-4Hp-2s UP cpi 052022-12-20
04260489020319KBL K7 pureSunK7-p-46-4Hp-0 UP ep 052022-12-20
04260489020326KBL K7 hybridSunK7-h-46-4Hp-2s UP cpi 052022-12-20
04260489020333KBL K7S extraSunK7S-e-46-4s-2s UP cpi 052022-12-20
04260489020340KBL K7S hybridSunK7S-h-46-4s-2s UP cpi 052022-12-20
04260489020227KBL Tower Space 3000 hybridSunT3/52-1802021-08-17
04260489020173KBL 8000 alpha extraSun+KBL 7908 - 50-6T12/4g 1616 int us (T)2021-08-02
04260489020241KBL 7900 alpha extraSun+KBL 7908 - 50-6T12/4g 1616 int us2021-08-02
04260489020258KBL 7000 alpha extraSun+KBL 6808 - 46-6T12/4g 1616 int us (T)2021-08-02
04260489020265KBL 5600 alpha extraSun+KBL 5600 - 42-2T12/4a - 1616 cpi u_us2021-08-02

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