FDA.reportPublic FDA data

Sharper Image

Primary DI
00840397513352
Brand
Sharper Image
Company
Merchsource, LLC
Model
1019357
Published
2026-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251531000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251531000AIR COMPRESSION BOOTS 1018195,1018196Merchsource, LLC2025-10-30IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840397513352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840397513352008403975133528403975133520840397513352

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic massagerAn pneumatically-powered device with a vibrating head mechanism which is typically held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head or pads may be interchangeable with others of different size and shape. It can be used for respiratory and physiotherapy treatment, typically in a hospital or institution, but is also suitable for home-use.

Contacts#

Phone, Email table
PhoneEmail
18003742744isupport@merchsource.com

Regulatory Flags#

DUNS number
121820737
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809040526721AIR RELAXMaxstar Industrial Co.,Ltd.IRP2026-04-27
08809802644885LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
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08809802644908LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809802644915LX9maxDAESUNG MAREF CO.,LTD.IRP2025-11-14
08809040526776Air Relax Classic Model AR-1.0 ControlUnit OnlyMaxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526783Air Relax Classic Model AR-1.0 Leg Recovery System-Size 2Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526790Air Relax Classic Model AR-1.0 Leg Recovery System-Size 3Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809040526806Air Relax Classic Model AR-1.0 Leg Recovery System-Size 4Maxstar Industrial Co.,Ltd.IRP2025-10-01
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.IRP2025-07-15
08809494000686CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809494000983CERAGEM Master V7CERAGEM Co., Ltd.IRP2025-02-12
08809802644526LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644533LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644540LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
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08809802644564LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644571LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644588LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644595LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644601LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644618LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644625LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644632LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644649LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644656LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20
08809802644663LF900DAESUNG MAREF CO.,LTD.IRP2024-05-20