FDA.reportPublic FDA data

HEALAX i Shoulder

Primary DI
08800132500025
Brand
HEALAX i Shoulder
Company
HANILMEDICAL CO.,LTD.
Model
CGM ESA-SD1501
Published
2021-06-22
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
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800132500025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800132500025088001325000258800132500025

GMDN Terms#

Term, Definition table
TermDefinition
Large-area electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687625082
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
08800132500001Ceramix mat M1CGM EMT-MS16012021-06-22
08800132500018Ceramix mat S1CGM EMT-SS16072021-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04055207069226NARichard Wolf GmbHISA2026-03-12
04055207069257NARichard Wolf GmbHISA2026-03-12
08809439110623WITHNIXWITHNIX CO.,LTDISA2026-03-06
08809439110630WITHNIXWITHNIX CO.,LTDISA2026-03-06
07630039101909MASTERPULS®Storz Medical AGISA2026-03-01
08057592610676IcooneI-TECH INDUSTRIES SRLISA2026-02-19
08800250280694QuadtheraECO DM LAB Co., Ltd.ISA2026-02-16
06973134771549silverfoxSilverfox Corporation LimitedISA2026-02-05
00851439007135PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007142PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007159PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007166PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007173PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007180PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007197PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00851439007203PanasonicPANASONIC CORPORATION OF NORTH AMERICAISA2026-01-22
00031262120243HomedicsHealth Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.ISA2026-01-15
08806109104555Centellian24 MADECA PRIME RITUAL WHITE PEARLDongkook Pharmaceutical Co.,Ltd.ISA2026-01-13
08806109105422Centellian24 MADECA PRIME MAXDongkook Pharmaceutical Co.,Ltd.ISA2026-01-13
10810140062892RENPHOJoicom CorporationISA2026-01-04
10810140062861RENPHOJoicom CorporationISA2025-12-16
08436560853152ToskaniTOSKANI SL.ISA2025-12-12
08436560853169ToskaniTOSKANI SL.ISA2025-12-12
10810140062854RENPHOJoicom CorporationISA2025-12-03
06970441320132AquafirmeXSBeijing Anchorfree Technology Co., Ltd.ISA2025-09-23
05391540830833Préime DermaFacialEMA AESTHETICS LIMITEDISA2025-09-15
10810140062670RENPHOJoicom CorporationISA2025-09-11
00860010877487WavonEase Seating SystemsISA2025-09-08