FDA.reportPublic FDA data

Homedics

Primary DI
00031262103307
Brand
Homedics
Company
Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
Model
MCS-382HJ
Device description
SHIATSU + KNEADING & VIBRATION CUSHION WITH SOOTHING HEAT
Published
2021-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10031262103304PackageGS12In Commercial Distribution
00031262103307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003126210330410031262103304
00031262103307000312621033070312621033070031262103307

GMDN Terms#

Term, Definition table
TermDefinition
Bed/chair electric massagerA mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.

Regulatory Flags#

DUNS number
544356011
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00031262120243HomedicsHHP-285HJ-RD2026-01-15
06971552170739MedisanaHM 1032024-11-19
06971552170746MedisanaHM 103P2024-11-19
00031262112286HomedicsSPE-320HJ2024-10-30
00031262116369HomedicsFMS-347HJ-BK2024-10-30
00031262116420HomedicsFMS-347HJ-RD2024-10-30
00031262116482HomedicsFMS-347HJ-GY2024-10-30
00031262112453HomedicsFMS-368HJ2024-09-03
00031262113740HomedicsFMS-401HJ-1PK2024-09-03
00031262113719HomedicsFMS-353HJ2024-08-30
00031262115218HomedicsMCS-116HJA2024-08-30
00031262115744HomedicsHHP-231J-GY2024-08-20
00031262112323HomedicsMCS-112HJ2024-08-15
00031262112859HomedicsSP-92HJ2024-08-15
00031262115430HomedicsFB-50J-BK2024-08-15
00031262114365HomedicsFB-50J-GY2024-07-30
00031262113702HomedicsFMS-347HJ2024-07-25
00031262112484HomedicsFB-50J-NV2024-07-15
00031262112491HomedicsFB-52J-LL2024-07-15
00031262112170HomedicsFMS-405HJAMZ-RM2024-07-03

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
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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
00810140061812RENPHOJoicom CorporationISA2024-11-19