Organization name

Shenzhen Roundwhale Technology Co., Ltd.

SRN

CN-MF-000021504

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

  1) Do not use this device if you are using a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic devices. Such use could cause electric shock, burns, electrical interference, or death. 2) The device should not be used when cancerous lesions or other lesions are present in the treatment area. 3) Stimulation should not be applied over swollen, infected, inflamed areas or skin eruptions (e.g. phlebitis, thrombophlebitis, varicose veins, etc.). 4) Electrode placements must be avoided in the carotid sinus area (anterior neck) or trans cerebrally (through the head). 5) This device should not be used in overly enervated areas. 6) Inguinal hernia. 7) Do not use on scarred areas following a surgery for at least 10 months after the operation. 8) Do not use with serious arterial circulatory problems in the lower limbs.

Primary placement in Spain; available across 32 countries total.

Trade name

Combo Electrotherapy Device

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

06971763600018

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

697176360CE000173

Reference / catalog number

R-C1

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Intended use TENS mode To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS mode 1.Relaxation of muscle spasms 2.Prevention or retardation of disuse atrophy 3.Increasing local blood circulation 4.Muscle re-education 5.Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis 6.Maintaining or increasing range of motion TENS and EMS can be used in the home or hospital, using the object (patient) must be 18 years or older of adults

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• N010103BIPOLAR NERVOUS ELECTROSTIMULATORS, BATTERY-POWERED

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.