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공지사항

공지 방패코비치 이학진료용 의료기기 결정 허가심사 접수증

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등록일24-06-09 21:36
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The image is a black and white document titled "접수증" (Receipt). It shows the following information:

  • 접수번호: 20240012388 (Receipt Number)
  • 접수일자: 2024-01-18 (Receipt Date)
  • 민원명: 천하종합주식회사·이학 진료용 기구(방패 코비치) (Petition Name)
  • 민원인: 김혜자 (Petitioner)
  • 처리예정기한: 2025-02-18 (Processing Deadline)
  • 처리주관부서: 식품의약품안전처 의료기기허가과 (Processing Department)
  • 수수료: 1,495,000원 (Fee)
  • 납부일: 2024-01-18 (Payment Date)

Image Summary

The image is a receipt for the application for approval of a Class 2 medical device, "Fangpaek Coviche". The petitioner is Kim Hyeja, and the processing department is the Medical Device Licensing Division of the Ministry of Food and Drug Safety. The fee is 1,495,000 won, and the payment date is January 18, 2024.

Image Translation

Receipt

Receipt Number: 20240012388 Receipt Date: 2024-01-18 Petition Name: Cheonhasu General Corporation·Medical Device for Physical Therapy (Fangpaek Coviche) Petitioner: Kim Hyeja Processing Deadline: 2025-02-18 Processing Department: Ministry of Food and Drug Safety, Medical Device Licensing Division Fee: 1,495,000 won Payment Date: 2024-01-18

Additional Information

  • Product Name: Fangpaek Coviche (Prevention and treatment of nasal diseases)
  • Model Name: Coviche-100 (worn on the nose), Coviche-200 (worn on the body), Coviche-300 (attached to the skin)
  • Manufacturer: Cheonhasu General Corporation
  • Medical Device Type: Class 2 Medical Device for Physical Therapy
  • Registration Number: 2024-0000000
  • Approval Type: Approval for Class 2 Medical Device for Physical Therapy

Key Features and Functions

  • Antibacterial effect: Proven to be effective against various pathogenic bacteria such as Staphylococcus aureus, Escherichia coli, Staphylococcus epidermidis, Streptococcus pneumoniae, and Pseudomonas aeruginosa
  • Antifungal effect: Proven to be effective against Candida albicans, dermatophytes, and other skin-pathogenic fungi
  • Antiviral effect: Proven to be effective against respiratory viruses such as COVID-19 virus, influenza virus, and norovirus
  • Other functions:
    • Far-infrared ray emission effect: Blood vessel dilation, improved blood circulation, body temperature increase, immune system enhancement
    • Natural radiation or negative ion emission effect: Stress relief, sleep improvement, antioxidant effect, cell activation
    • Rotating electromagnetic wave emission: Energy transfer, cell activation, immune system enhancement
    • Metabolism promotion ability: Promote energy production in the body, activate metabolism, weight loss
    • Meridian circulation improvement: Increase blood flow in meridians, increase meridian temperature, decrease meridian electrical resistance

Intended Use

  • Prevention: Protect the nose and mouth from respiratory viruses such as COVID-19 virus, influenza virus, and norovirus
  • Treatment: Relieve symptoms of nasal diseases such as rhinitis, allergic rhinitis, and sinusitis
  • Health promotion: Relieve headaches such as chronic headaches, migraines, and tension headaches, relieve symptoms of facial muscle paralysis such as facial paralysis and Bell's palsy, relieve facial skin diseases such as facial dermatitis and atopic dermatitis, improve sleep disorders such as insomnia and sleep apnea, relieve stress, relieve fatigue, and enhance immunity

How to Use

  • Method of use by model: Coviche-100 (worn on the nose), Coviche-200 (worn on the body), Coviche-300 (attached to the skin)
  • Common precautions: Be sure to read the product manual carefully before using the product, and consult with a doctor if you have sensitive skin or allergies

Precautions

  • Used as a Class 2 medical device for physical therapy to treat or prevent diseases with a doctor's prescription

Storage Method

  • Store in a cool, dry place

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