FDA.report

SHARPER IMAGE

Primary DI
06973305010033
Brand
SHARPER IMAGE
Company
Zhejiang Lumeng Health & Technology Co., Ltd.
Model
723070-507
Published
2020-06-23
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

Related Records

Product Codes

CodeName
IRTPad, Heating, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06973305010033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06973305010033069733050100336973305010033

GMDN Terms

TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.

Sterilization Methods

Method

Regulatory Flags

DUNS number
421341654
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 DIBrandModelCatalogPublished
06973305010217SHARPER IMAGECH2-6CWT47012/CWT02106/CWT05112/31424A/31580/CWT340062022-05-03
06973305010224SHARPER IMAGECH2-9CWT48012/CWT03106/315792022-05-03
06973305010231SHARPER IMAGECHC-3CCZ010042022-05-03
06973305010248SHARPER IMAGECHNW-3CWT180042022-05-03
06973305010255SHARPER IMAGECHKW-5CWT16003/316892022-05-03
06973305010262SHARPER IMAGECH2-9LCWT04106/CWT32003/31456/315812022-05-03
06973305010279SHARPER IMAGECHJ-9315782022-05-03
06973305010286Calming Heat Sauna WrapCHSW-3CWT42001/317832022-05-03
06973305010071SHARPER IMAGE315802020-11-03
06973305010088SHARPER IMAGE315792020-11-03
06973305010095SHARPER IMAGE315812020-11-03
06973305010200All star316902021-12-30
06973305010194All star7716442021-09-30
06973305010187All star316952021-06-23
06973305010156All starCWT180042021-04-30
06973305010163All star316332021-04-30
06973305010170All starCWT170032021-04-30
06973305010118All star315822021-04-12
06973305010149All star315832021-04-12
06973305010101SHARPER IMAGECWT120062020-12-22

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00846841092596mibestBeijing Choice Electronic Technology Co., Ltd.IRT2025-07-23
00860163001517BIOMAT QUEENRICHWAY & FUJI BIO INC.IRT2025-06-16
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00860163001531BIOMAT SINGLERICHWAY & FUJI BIO INC.IRT2025-06-16
00860163001548BIOMAT MINIRICHWAY & FUJI BIO INC.IRT2025-06-16
00860163001555BIO-BELTRICHWAY & FUJI BIO INC.IRT2025-06-16
10041298991967DMID-M-S HOLDINGS, INC.IRT2025-06-12
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00810140062147RENPHO Heating PadJoicom CorporationIRT2025-05-29
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00810140062215iDOO Heating PadJoicom CorporationIRT2025-05-29
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