Enterprise name Guangzhou Kangzheng Economic and Technological Development Co. Production Permit No. 20010260
Registered Address 3rd Floor, No. 5 Hengling 2nd Road, Tianhe District, Guangzhou City
Production Address 3rd Floor, No. 5 Hengling 2nd Road, Tianhe District, Guangzhou City
License Form Permit Matters Changes
Date of Issue 2013-8-28
Effective Deadline 2016-8-8
Certificate Status Normal
Registration Certificate No. 粤食药监械（准）字2013第2261407号
Enterprise Name Guangzhou Kangzheng Economic and Technological Development Co. Ltd
Product Name Microcomputer Pulse Therapeutic Instrument
Standard Record No. YZB/Guangdong 0659-2013 Microcomputer Pulse Therapeutic Instrument
Specification No. ek-100, ek-101, ek-103, ek-801, ek-803, ek-805, ek-816, ek-806, ek-807, ek-808, ek-811, ek-813, ek-817, ek-818, ek-821, ek-823, ek-825, ek-865Ⅱ, ek-848 863, EK-848Ⅱ, EK-832, EK-831Ⅱ, EK-828, EK-867Ⅱ, EK-881, EK-873, EK-888, EK-878, EK-885, EK-883, EK-891, EK-896, EK-852, EK-898, EK-895
Product Performance, Structure and Composition EK-100, EK-101, EK-103, EK-801, EK-803, EK-805, EK-816, EK-806, EK-807, EK-808, EK-811, EK-813, EK-817, EK-818, EK-821, EK-823, EK-825, EK-865 II, EK-863, EK-848II, EK-832, EK-831II, EK-828, EK-867II, EK-881, EK-888, EK-878, EK-885, EK-883 models consist of a main unit, skin electrodes, ultrasonic head, laser head, and a thermal effect band; EK-873, EK-891, EK-896, EK EK-873, EK-891, EK-896, EK-852, EK-898, EK-895 are composed of host, battery, skin electrode and laser head. Output frequency 1HZ - 8000HZ, output load for 500Ω ± 10%, output amplitude, frequency pulse width corresponding to 500Ω when the change does not exceed ± 10%. Electrical stimulation, pulse frequency should be in the range of 1HZ - 8000HZ, the output pulse voltage should be in the range of 0Vp-p - 180 Vp-p. Laser wavelength of 650nm ± 10%, laser mode for continuous output, the terminal power should be within the range of 0.1mw - 5mw. Terminal output laser power instability S should be better than ± 10%. Terminal output laser power reproducibility Rp should be better than ±10%.
Product application/intended use Suitable for the adjuvant treatment of arthritis, sciatica, soft tissue injury, muscle strain and the relief of neck, shoulder, lumbar and leg pain.
Enterprise Address 3rd Floor, No.5 Hengling 2nd Road, Tianhe District, Guangzhou City
Date of Issue 2014-12-9
Effective Deadline 2017-12-30
Name of Commodity Digital Therapeutic Apparatus
Performance Indicator
Remarks
Registration No. Guangdong Food and Drug Supervision and Regulation of Measures (Quasi) Word 2014 No. No. 2240064
Enterprise name Guangzhou Kangzheng Economic and Technological Development Company Limited
Product name Semiconductor laser therapeutic instrument
Standard filing No. YZB/Guangdong 0692-2013 "Semiconductor laser therapeutic instrument"
Specification model JG-801, JG-803, JG-805, JG-806
Product performance, structure and composition by the host, built-in 3 No. 7 battery batteries or external USB 5V power supply line, nasal plug laser head composed of ", the laser wavelength of 650nm ± 10%, the laser mode of continuous output, the internal power supply voltage d.c.4.5V, the terminal output laser power instability St should be better than ± 10%. Terminal output laser power reproducibility Rp should be better than ±10%. Spot diameter: wrist-type spot head should be 4nm ± 10%, nasal spot head should be 2nm ± 10%.
Product Scope of Application/Intended Use Transnasal irradiation for assisting in the reduction of blood viscosity.
Enterprise Address 3rd Floor, No. 5, Hengling 2nd Road, Tianhe District, Guangzhou City
Date of Issue 2014-1-14
Effective Deadline 2018-1-13
Goods Name
Performance Indicators
Remarks