FDA.reportPublic FDA data

Huamei

Primary DI
06973512860513
Brand
Huamei
Company
Shandong Huamei Technology Co.,Ltd.
Model
HM-C100
Published
2020-10-29
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
06973512860513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973512860513069735128605136973512860513

GMDN Terms#

Term, Definition table
TermDefinition
Liquid-jet skin surface treatment system control unitAn electrically-powered, mobile (on wheels) device intended to create a high-pressure aerosol of liquid (e.g., water, saline, herbal solution) for application to the skin for cosmetic skin treatment procedures (e.g., skin rejuvenation, facial deep cleansing, reduction of hair loss, removal of scars). It consists of a main unit with air/liquid pumps, a user-interface and controls, and is used with a dedicated applicator (not included).

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
06973512860742HuameiHM-EMS6002021-04-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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088095244977453H Smart Massage Bed3H, Co., LtdISA2026-07-29
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00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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