FDA.reportPublic FDA data

Homedics

Primary DI
00031262108968
Brand
Homedics
Company
Smart Home Branch of Zhangzhou Easepal Industrial Corporation
Model
SP-6HJ-GY-2
Device description
Shiatsu massage cushion with heat
Published
2023-08-20
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
00031262108968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00031262108968000312621089680312621089680031262108968

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
416114043
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973368290052MedisanaEM 5002025-02-15
06973368290038MedisanaHM 3052024-11-26
06973368290045MedisanaHM 305B2024-11-26
00031262112477HomedicsMCS-116HJA-22024-08-20
00031262113009HomedicsHHP-285HJC-22024-08-20
00031262113054HomedicsSP-6HJA-GY-22024-08-20
00031262114372HomedicsFB-50J-BK-22024-08-20
00031262113016HomedicsHHP-231JA-22024-08-10
00031262112460HomedicsFMV-400HJB-BK-22024-07-20
00031262108517HomedicsFMV-400HJ-GY-22023-08-20
00031262108883HomedicsMCS-116HJ-22023-08-20
00031262108937HomedicsHHP-231J-22023-08-20
00031262109002HomedicsHHP-285HJB-22023-08-20
00031262109040HomedicsFB-50JB-BL-22023-08-20
00031262109057HomedicsFB-52JB-PK-22023-08-20
00031262107114HomedicsHHP-285HJA-22022-08-20
00031262107169HomedicsFB-50JA-BL-22022-08-20
00031262107176HomedicsFB-52JA-PK-22022-08-20
00031262107237HomedicsFMV-400HJA-BK-22022-08-20
00031262107398HomedicsFB-52J2022-08-20

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
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00045915831479Human TouchHuman Touch, LLCISA2026-01-12
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00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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