Certifications
Certifications & Approvals
Painfree8800 is a trusted medical device with KFDA approval and New Medical Technology certification
Regulatory Status
Certifications
01
KFDA
KFDA Approval
Korean Ministry of Food and Drug Safety approval
202002
NMT
New Medical Technology
Korean Ministry of Health and Welfare recognition
2013Certification Details
KFDA
MFDS Medical Device Manufacturing License
Class 3 medical device manufacturing and sales approval
NMT
New Medical Technology Assessment Recognition
PSC therapy safety and efficacy recognition (MOHW Notice No. 2013-97)
Device Classification
Medical Device Classification
| Treatment Modality | Product Code | Class |
|---|---|---|
| Medical Laser Irradiator | A37020.01 | Class 3 |
| Transcutaneous Pain Relief Electrical Stimulator | A16010.03 | Class 2 |
| Ultrasound Stimulator | A16090.01 | Class 2 |
| Medical Electromagnetic Generator | A85020.01 | Class 2 |
| Low-frequency Stimulator | A16010.01 | Class 2 |
| Medical Thermal Device | A16150.01 | Class 2 |
Legal Documentation
Licenses & Patents
Medical Device Manufacturing Licenses
Medical Device Manufacturing License
- License Number
- 제 6094 호
- Issue Date
- 2018.05.23
- Issuing Authority
- Seoul Regional MFDS
Medical Device Manufacturing Approval (PAINFREE-8800)
- License Number
- 제허 20-20 호
- Issue Date
- 2020.01.09
- Issuing Authority
- Ministry of Food and Drug Safety
Design Registration
Design Registration Certificate (Medical Electrical Stimulator)
- Registration Number
- 30-1048945
- Registration Date
- 2020.03.02
- Issuing Authority
- Korean Intellectual Property Office
Quantum Aqua Certification
KC
Quantum Aqua KC Certification
- License Number
- R-R-aq7-퀀텀Aqa
- Issuing Authority
- National Radio Research Agency (KC)
Certification Inquiries
Please contact us if you need certificate copies or additional information.
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