DEVICE: KBL beautyShaper (04260489020180)

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Device Record History
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Device Identifier (DI) Information
KBL beautyShaper
T3/50-180-c
In Commercial Distribution

KBL GmbH
04260489020180
GS1

1
341936227 *Terms of Use
This product is an over-the-counter powered exerciser emitting very bright light.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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Yes
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GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58270 Vibration platform exerciser, stationary
A 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BXB Exerciser, Powered
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
da5e3934-d5c7-4126-b17d-20b7ff0ef2fa
December 18, 2020
1
December 10, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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