FDA.reportPublic FDA data

Lucky Dragon

Primary DI
06975869110228
Brand
Lucky Dragon
Company
LUCKY DRAGON ENTERPRISE GROUP INC.
Model
LD230217
Device description
RQ ROLLER RQ GUASHA SET
Published
2024-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LYGMassager, Therapeutic, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYGMassager, Therapeutic, ManualPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975869110228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975869110228069758691102286975869110228

GMDN Terms#

Term, Definition table
TermDefinition
External manual massager, home-useA manual (non-powered) device specifically designed to apply external massage in the home. It is typically held in the hand of the user and drawn/rolled across the area of the body/muscles to be treated; it may also be designed to be placed on the floor for foot massage. The massaging components, e.g., roller heads or pads, may be interchangeable with others of different size and shape. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
854861621
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
06975869110051Lucky DragonLD1117022024-11-25
06975869110082Lucky DragonLDFS0982024-11-25
06975869110198Lucky DragonLDFS09272024-11-25
06975869110242Lucky DragonLD2302152024-11-25
06975869110266Lucky DragonLDG230142024-11-25
06975869110297Lucky DragonLD2302142024-11-25
06975869110303Lucky DragonLD2302242024-11-25
06975869110310Lucky DragonLD2350142024-11-25
06975869110341Lucky DragonLD230142024-11-25

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