FDA.reportPublic FDA data

Sharper Image

Primary DI
00840397501120
Brand
Sharper Image
Company
Merchsource, LLC
Model
1018015
Published
2024-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00840397501120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840397501120008403975011208403975011200840397501120

GMDN Terms#

Term, Definition table
TermDefinition
Portable sequential venous compression systemA compact portable system designed for the noninvasive treatment and prevention of venous disorders and sequelae (lymphatic, arterial, trauma) by facilitating better vascular flow, as well as minimizing venous stasis during/after surgery and immobilization. It applies sequential pressure to a patient's arm or leg to promote venous blood flow and typically consists of an electrically-powered compression pump, control/timing mechanism, rechargeable batteries, and tubing that connect to an integral cuff or pneumatic stockings that inflate and deflate sequentially. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized/institutionalized patients.

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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Primary DIBrandCompanyProduct codePublished
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00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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