FDA.reportPublic FDA data

Huamei

Primary DI
06973512860742
Brand
Huamei
Company
Shandong Huamei Technology Co.,Ltd.
Model
HM-EMS600
Published
2021-04-23
Public version status
Update
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
06973512860742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973512860742069735128607426973512860742

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
540583132
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973512860179HuameiHM-DL2202023-05-19
06973512860148HuameiHM-DL8002022-10-21
06973512860155HuameiHM-DL9002022-10-21
06973512860162HuameiHM-DL6002022-10-21
06973512860117HuameiHM-DL1002020-10-29
06973512860124HuameiHM-DL2002020-10-29
06973512860131HuameiHM-DL3002020-10-29
06973512860711HuameiHM-EMS1002021-04-23
06973512860728HuameiHM-EMS2002021-04-23
06973512860735HuameiHM-EMS3002021-04-23
06973512860759HuameiHM-EMS7002021-04-23
06973512860766HuameiHM-EMS8002021-04-23
06973512860773HuameiHM-EMS9002021-04-23
06973512860056HuameiEROSE-YA2023-05-09
06973512860063HuameiEROSE-YB62023-05-09
06973512860032HuameiHM-IPL-J12022-10-21
06973512860049HuameiHM-IPL-J22022-10-21
06973512860322HuameiHM-PDT1002022-10-21
06973512860339HuameiHM-PDT2002022-10-21
06973512860346HuameiHM-PDT5002022-10-21

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