FDA.reportPublic FDA data

Medisana

Primary DI
06973368290052
Brand
Medisana
Company
Smart Home Branch of Zhangzhou Easepal Industrial Corporation
Model
EM 500
Published
2025-02-15
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
06973368290052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973368290052069733682900526973368290052

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
416114043
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00031262108968HomedicsSP-6HJ-GY-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
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
00810140061812RENPHOJoicom CorporationISA2024-11-19
00810140061829RENPHOJoicom CorporationISA2024-11-19