FDA.reportPublic FDA data

Huamei

Primary DI
06973512860414
Brand
Huamei
Company
Shandong Huamei Technology Co.,Ltd.
Model
HM-PL100
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
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973512860414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973512860414069735128604146973512860414

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy ultrasound systemAn assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.

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

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Primary DI, Brand, Company table
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08053782383733T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-03-25
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