FDA.reportPublic FDA data

Sharper Image

Primary DI
00843479178845
Brand
Sharper Image
Company
Merchsource, LLC
Model
1016637
Published
2024-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
00843479178845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843479178845008434791788458434791788450843479178845

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

Contacts#

Phone, Email table
PhoneEmail
18003742744isupport@merchsource.com

Regulatory Flags#

DUNS number
121820737
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840397513215Sharper Image10193412026-04-23
00840397513284Sharper Image10193482026-02-17
00840397501151Sharper Image10180182025-09-22
00840397503223Sharper Image10182392025-09-22
00840397517961Sharper Image10198522025-06-06
00843479127003Sharper Image10126542025-01-01
00843479157772Sharper Image10149632024-08-03
00843479107487Sharper Image10118522024-06-01
00843479107494Sharper Image10118532024-06-01
00843479107500Sharper Image10118542024-06-01
00843479108552Sharper Image1012070,1012654, 10171912024-06-01
00843479124149Sharper Image10122872024-06-01
00843479126259Sharper Image10125492024-06-01
00843479137637Sharper Image10135392024-06-01
00843479157758Sharper Image10149612024-06-01
00843479159653Sharper Image10152432024-06-01
00843479166262Sharper Image1016761, 10153522024-06-01
00843479185256Sharper Image10173392024-06-01
00843479198263Sharper Image10107662024-06-01
00843479164954Sharper Image10098222024-04-17

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