FDA.reportPublic FDA data

Homedics

Primary DI
00031262108609
Brand
Homedics
Company
ZHANGZHOU EASEPAL INNOVATION CO., LTD.
Model
FMS-370HJ
Device description
Foot Massager
Published
2023-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00031262108609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00031262108609000312621086090312621086090031262108609

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
546535934
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973534130250FED fitnessEP-11292026-05-20
00031262102171HomedicsSP-250HJ2021-06-20
00031262102607HomedicsNMS-685HJ2021-07-15
00031262103208HomedicsHHP-810HJ2021-06-01
00031262104557HomedicsHHP-735HJ2021-06-01
00031262106971HomedicsNMS-390HJ2022-06-15
00031262107121HomedicsNMS-240HJA-22022-06-24
00031262102119HomedicsNMSQ-216HJA-22022-06-24
00006524176610HomedicsNMS-240HJA-22022-06-24
00031262114129HomedicsSPE-CP110HJ2024-07-04
00031262115522HomedicsNMS-390HJ-WMT2024-06-25
00031262113023HomedicsNMSQ-216HJAGY-22024-06-18
00031262115348HomedicsNMS-240HJA2024-06-18
00031262112521HomedicsFMS-370HJA-22024-06-11
00031262113085HomedicsNMS-390HJ-22024-06-07
00031262110695HomedicsFMS-370HJ2023-12-06
00031262108807HomedicsSR-10J2023-06-15
00031262108982HomedicsNMSQ-216HJ-GY-22023-06-15
00031262109064HomedicsSPE-110HA-22023-06-15
00031262109095HomedicsNMSQ-217HJ-TN2023-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071298017Smart-RSTHyperion Medical Technologies, Inc.ISA2026-06-02
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
00810140061355RENPHOJoicom CorporationISA2024-11-19
00810140061362RENPHOJoicom CorporationISA2024-11-19
00810140061379RENPHOJoicom CorporationISA2024-11-19
00810140061386RENPHOJoicom CorporationISA2024-11-19
00810140061393RENPHOJoicom CorporationISA2024-11-19
00810140061409RENPHOJoicom CorporationISA2024-11-19
00810140061416RENPHOJoicom CorporationISA2024-11-19
00810140061447RENPHOJoicom CorporationISA2024-11-19
00810140061690RENPHOJoicom CorporationISA2024-11-19
00810140061706RENPHOJoicom CorporationISA2024-11-19
00810140061768RENPHOJoicom CorporationISA2024-11-19
00810140061782RENPHOJoicom CorporationISA2024-11-19
00810140061799RENPHOJoicom CorporationISA2024-11-19
00810140061805RENPHOJoicom CorporationISA2024-11-19
00074108453488CONAIRCONAIR CORPORATIONISA2024-10-07