Certificate 1 · Government registration
Registered with Malaysia's Ministry of Health (KKM–MDA)
In simple terms: Dr Kiseki® is officially registered with the Medical Device Authority (MDA) under Malaysia's Ministry of Health (KKM). That means a government body has reviewed and recognised it as a registered medical device, not just a product supported by customer stories.
Because it is officially registered, the registration can be looked up on the MDA's own website, so anyone can confirm it is genuine.
Registered under the Medical Device Authority (MDA), Ministry of Health Malaysia.
The registration is searchable on the official MDA website.
Recognised as a registered medical device, not based only on testimonials.
Certificate 2 · Company licence
The company itself is a licensed medical-device establishment
In simple terms: it is not only the device that is registered, the company behind it is also licensed. The MDA has granted U C Health Marketing Sdn Bhd an official Establishment Licence as a manufacturer under Malaysia's Medical Device Act 2012.
This means the business is recognised and held accountable by the government, not just the product, an extra layer of trust behind everything Dr Kiseki® makes.
The company is licensed by the MDA as a medical-device manufacturer.
Issued under the same law as the device registration (Act 737).
Adds accountability at the company level, on top of the product.
Certificate 3 · Registered uses
The official MDA Attachment lists Neuromuscular Conditions
Every MDA registration comes with an official attachment (called Lampiran 1) that spells out exactly what the device is registered for. This is part of the same government record.
The attachment states that the DK-2000 is applicable as an adjuvant (supportive) treatment for physical pain such as neck, shoulder, waist and hip pain. As well as scapulohumeral periarthritis (frozen-shoulder-related discomfort) and neuromuscular conditions. "Neuromuscular" simply means anything to do with the nerves and muscles working together.
This matters because it is not just based on testimonials. the official MDA attachment itself specifically lists neuromuscular conditions.
An official attachment that forms part of the MDA registration.
Lists physical pain, frozen-shoulder-related support and neuromuscular conditions.
Registered device: DK-2000 Wave Therapy (Class B, brand Dr Kiseki).
Certificate 4 · Quality standard
Made to the international medical-device quality standard
In simple terms: ISO 13485:2016 is the worldwide quality-management standard written specifically for medical devices. It sets the rules for how a device should be made, checked and handled.
Holding this certificate means the factory and processes behind Dr Kiseki® are audited to those international medical-grade rules, so what you receive is produced under consistent, controlled quality standards, not made in an ad-hoc way.
The quality system follows ISO 13485:2016.
The factory and its processes are audited under medical-device quality standards.
Reflects international, medical-grade quality control. In short, Hospital-grade
Certificate 5 · Independent testing
Independently tested and passed by SGS
SGS is one of the world's most recognised independent testing and certification companies. "Independent" means they are a neutral third party. Not Dr Kiseki, so the testing is unbiased.
Dr Kiseki® was put through SGS's strict testing and passed, which the company notes makes it the only home-use device of its kind to have achieved this recognition.
A neutral, third-party check that the device performs and behaves as it should.
Certificate 6 · Electrical safety
Tested to international electrical-safety standards
"IEC 60601" is the international rule-book for the safety of medical electrical equipment, and "IEC 60335" covers home electrical appliances. Each number below is a specific safety test the device has passed. In plain terms, they all check the same thing from different angles: that the device is safe to plug in and use at home.
Meets the core safety rules for any medical electrical equipment.
Confirmed safe and user-friendly to use in a home setting.
Meets the specific safety rules for nerve and muscle stimulation devices.
Checked to be easy and safe to operate without confusion.
Won't interfere with, or be disrupted by, other nearby electronics.
Certificate 7 · SIRIM certified
Tested by SIRIM as a safe home electrical device
In simple terms: SIRIM is Malaysia's national testing and certification body. When a product carries a SIRIM certificate, it has been checked to meet Malaysia's own safety rules for electrical goods.
Dr Kiseki® is SIRIM certified to IEC 60335-1, the standard for the safety of household electrical appliances so you can plug it in and use it at home with peace of mind.
Certified by SIRIM, Malaysia's national standards and testing body.
Meets IEC 60335-1 : the safety standard for home electrical appliances.
Recognised as safe to use in a normal home setting.
You don't have to take our word for it
The MDA registration can be checked on the Medical Device Authority's official website using the registration number. If you'd like help understanding any of it, our team is happy to walk you through it.
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