FDA.reportPublic FDA data

Homedics

Primary DI
00031262112286
Brand
Homedics
Company
Health Care Massage Branch of Zhangzhou Easepal Industrial Co., Ltd.
Model
SPE-320HJ
Device description
eye massager with heat
Published
2024-10-30
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
00031262112286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00031262112286000312621122860312621122860031262112286

GMDN Terms#

Term, Definition table
TermDefinition
Wearable electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It is typically in the form of a wearable wrap containing vibrating nodes that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This is a home-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544356011
Device count
1
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
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
00031262110664HomedicsBM-AC111HJ2023-12-20

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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00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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