EC Certficate Production Quality Assurance System FI20/07020 ‘The management sysiem of Guangzhou Longest Science & Technology Co., Ltd. 586F,, Building B4, No. 11, Kaiyuan Avenue, Science City, ‘Guangzhou Hi-tech industrial Development Zone, 510530, Guangzhou, Guangdong Province, PR. China has been assessed and certied as meeting the requirements of Directive 93/42/EEC ‘on Medical Devices, Annex V For the following products Portable Electro-Stimulation Therapy Devices Active Passive Trainer for Upper and Lower Limbs Products covered are stdin Ntachmert1fs cents This certificate is valid from 05 April 2021 until 24 May 2024 and remains valid subject to satisfactory surveillance audits. Issue 2. Cetified since 02 November 2020 This certification is based on decision: F121/07035P0 ‘Authorised by ste ae Jani Hogman Certifier £08 ns is. ato 98 Tatomet 8-080 Hetil Flan 988606951 #9889 6025474 wo.s.coN scsi 2 FINAS ‘on8 (en BONE 1708)Attachment 1 to SGS Fimko Ltd. EC certificate F120/07020, Issue 2 Manufacturer Guangzhou Longest Sclence & Technology Co., Lid. ‘Address ‘AGF, Bulding B4, No.11, Kaiyuan Avenue, Scence Ciy, ‘Guangzhou Hi-tech Industral Development Zone, 510530, Guangzhou, Guangdong Province, PR China Activity and Medical ‘9B/42IEEC Annex V Device Product Category _| Active Passive Trainer for Upper and Lower Limos Portable Electto-Slimulation Therapy Devices List of medical devices and the comesponding typelmodel markings with product rademarks/marketing names for Upper and Lower Limbs covered by this certificate: dical Device Class ‘Trademark(s) and Model(s)type(s) Active Passive Trainer | lla LGT-§100D Portable Electro- ‘Stimulation Therapy Ta Devices. TGT-237, LGT-235 Page 2012Page 1/1 DECISION 06 April 2021 F121/07035P0 — Guangzhou Longest Science & Technology Co., Ltd 586F, Building B4, No.11, Kaiyuan Avenue, Science City, Guangzhou Hi-tech Industrial Development Zone, 510530, Guangzhou, Guangdong Province, PR. China EC-certification application 18/086-2, dated 2020-09-03 Subject Extension of product range (Models LGT-231, LGT-235), based on Council Directive 93/42/EEC concerning medical devices, Annex V. Manufacturer Guangzhou Longest Science & Technology Co., Ltd 586F,, Building B4, No.11, Kaiyuan Avenue, Science City, Guangzhou Hitech Industrial Development Zone, 510530, Guangzhou, Guangdong Province, P.R. China Decision A certificate will be issued for the manufacturer. The certificate covers the following products: Product Model Class Active Passive Trainer LGT-5100D Wa for Upper and Lower Limbs Portable Electro- LGT-231, LGT-235 la ‘Stimulation Therapy Devices Justification 'SGS Fimko Lid has assessed manufacturer's quality management system ‘and products. Quality management system and products meet the requirements of Annex V of Medical Device Directive 93/42/EEC, The decision is based on technical fle review report(s) 291479, dated 21 March 2021. “The manufacturer has signed the undertaking to follow the obligations of ‘Annex V of the Directive 83/42/EEC. Certificate related F120/07020, Issue 2 to decision Attachment to Attachment 1 certificate Valid until ‘This decision is valid until 24 May 2024 providing the requirements of the certification are futfilled Date Helsinki, 06 April 2021 Vain Jani Hogman, Certifier SGS Fimko Lid, Notified Body 0598 159358 9696 361 won sg |S08 Fimke Lit | Takorte 8, F-00360 Hels, Finland Tiere DOSS — Mane ohe SOS Gs SGBEN