DECLARATION OF CONFORMITY

Company owner

Sławomir Wroński

COMPANY

REH4MAT Sławomir Wroński

DECLARESthat product:

marked with the CE sign is Class I medical device, of rule 1, consistent with the requirementsof the Council Directive 93/42 / EEC of 14 June 1993 on medical devices and the Law of 20

MayN2010 on medical devises (Journal of Laws of 2015, No. 876, as amended).Conformity assessment was carried out on the basis of the VII Council Directive 93/42 /EEC.

The product meets the requirements of the harmonized standards:

PN-EN 1041+A1:2013-12 I

PN-EN 12182:2012 Assistive products for persons with disability. General

requirements and test methods

PN-EN ISO 13485:2016 Medical Devices - Quality Management Systems -

Requirements for Regulatory Purposes

PN-EN ISO 14971:2012 Medical devices. Application of risk management to medical

device

PN-EN ISO 15223-1:2017-02 Medical devices Symbols to be used with medical device

labels,labelling and information to be supplied - Part 1:General requirements

nformation supplied by the manufacturer of medical devices

52/D/EN/3

LOWER-EXTREMITY SUPPORT

THIS DECLARATION HAS BEEN ISSUED ON THE RESPONSIBILITY OF THE COMPANY REH4MAT Sławomir Wroński, 36-060 Głogów Małopolski, ul. Piaski 47, POLAND

Country of origin: POLAND

page 1/4

LIST OF ITEMS IN APPENDIX NO.1

No. 52/D/EN/3

Głogów Małopolski., 04.03.2019

52/D/EN/3

PRODUCT:

MODEL:

page 2/4

APPENDIX NO. 1TO DECLARATION OF CONFORMITY NO. 52/D/EN/3

LOWER-EXTREMITY SUPPORT

ź LOWER-EXTREMITY SUPPORT AM-KDX-01ź LOWER-EXTREMITY SUPPORT AM-KDX-02ź LOWER-EXTREMITY SUPPORT AM-KDX-03ź LOWER-EXTREMITY SUPPORT IB-SK/Aź LOWER-EXTREMITY SUPPORT IB-SK/2ź LOWER-EXTREMITY SUPPORT EB-SK/Pź LOWER-EXTREMITY SUPPORT IB-SK/2RAź LOWER-EXTREMITY SUPPORT IB-SK/1Rź LOWER-EXTREMITY SUPPORT IB-SKL/2RAź LOWER-EXTREMITY SUPPORT IB-SKL/1Rź LOWER-EXTREMITY SUPPORT IB-SKL/3ź LOWER-EXTREMITY SUPPORT ATTACK 1Rź LOWER-EXTREMITY SUPPORT ATTACK 2RAź LOWER-EXTREMITY SUPPORT ZEUSź LOWER-EXTREMITY SUPPORT AM-TUD-KD-03ź LOWER-EXTREMITY SUPPORT OKD-04ź LOWER-EXTREMITY SUPPORT OKD-05ź LOWER-EXTREMITY SUPPORT OKD-06ź LOWER-EXTREMITY SUPPORT OKD-07ź LOWER-EXTREMITY SUPPORT OKD-08ź LOWER-EXTREMITY SUPPORT OKD-09ź LOWER-EXTREMITY SUPPORT EB-SK/Fź LOWER-EXTREMITY SUPPORT SPARTANź LOWER-EXTREMITY SUPPORT OKD-Z/Fź LOWER-EXTREMITY SUPPORT RAPTORź LOWER-EXTREMITY SUPPORT ATOMź LOWER-EXTREMITY SUPPORT AM-OSK-O/1R-01ź LOWER-EXTREMITY SUPPORT AM-OSK-Z/1R-01ź LOWER-EXTREMITY SUPPORT AM-OSK-ZL/1R-01ź LOWER-EXTREMITY SUPPORT AM-OSK-OL/1R-01ź LOWER-EXTREMITY SUPPORT AM-KD-AM/1R-01ź LOWER-EXTREMITY SUPPORT OKD-01ź LOWER-EXTREMITY SUPPORT OKD-02ź LOWER-EXTREMITY SUPPORT OKD-03ź LOWER-EXTREMITY SUPPORT OKD-03/10ź LOWER-EXTREMITY SUPPORT OKD-03/20ź AM-OSK-ZL/3

ź AM-OSK-OL/3ź EB-SK/Aź AM-OSK-Z/S-Aź AM-OSK-ZJ/3ź EB-SK/1Rź EB-SKL/3ź EB-SKL/2RAź EB-SKL/2RA-ACLź AM-KD-AM/1REź AM-KD-AM/1RE-03ź AM-KD-AM/2RA-03ź AM-KD-AM/1RE-02ź AM-KDS-AM/1REź AS-SK/Aź EB-SK/2ź EB-SK/2RAź AM-OSK-Z/2RA-ORź AM-KD-AM/3-03ź EB-SKL/1Rź AM-OSK-ZL/2RA-ACLź AM-KD-AM/1RE-ACLź AM-KD-AM/2R-03ź AM-KDS-AM/1RE-02ź AM-KD-DAM/1Rź AM-KD-AJ/2Rź AM-KDS-AJ/2Rź AM-KD-AM/1Rź AM-KD-AM/2Rź AM-KD-AM/2R-02ź AM-KDS-AM/2Rź AM-KDS-AM/2R-02

AM-DOSK-O/1Rź AM-DOSK-Z/1Rź AM-OSK-Z/1Rź AM-OSK-O/1Rź AM-OSK-Z/2Rź AM-OSK-Z/2R-02

Company owner

Sławomir Wroński

Głogów Małopolski., 04.03.2019

52/D/EN/3

PRODUCT:

MODEL:

page 3/4

APPENDIX NO. 1TO DECLARATION OF CONFORMITY NO. 52/D/EN/3

LOWER-EXTREMITY SUPPORT

ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-09ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-10ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-11ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-12ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-13ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-14ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-15ź LOWER-EXTREMITY SUPPORT 4ARMY-SB-01ź LOWER-EXTREMITY SUPPORT 4ARMY-SB-02ź LOWER-EXTREMITY SUPPORT 4ARMY-SB-03ź LOWER-EXTREMITY SUPPORT 4ARMY-SB-04ź LOWER-EXTREMITY SUPPORT 4ARMY-SB-05ź LOWER-EXTREMITY SUPPORT 4ARMY-U-01ź LOWER-EXTREMITY SUPPORT 4ARMY-U-02ź LOWER-EXTREMITY SUPPORT 4ARMY-U-03ź LOWER-EXTREMITY SUPPORT 4ARMY-U-04ź LOWER-EXTREMITY SUPPORT 4ARMY-U-05ź LOWER-EXTREMITY SUPPORT 4ARMY-PU-01ź LOWER-EXTREMITY SUPPORT 4ARMY-PU-02ź LOWER-EXTREMITY SUPPORT 4ARMY-PU-03ź LOWER-EXTREMITY SUPPORT 4ARMY-PU-04ź LOWER-EXTREMITY SUPPORT 4ARMY-PU-05ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-01ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-02ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-03ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-04ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-05ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-06ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-07ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-08ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-09ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-10ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-11ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-12ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-13ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-14ź LOWER-EXTREMITY SUPPORT 4ARMY-SS-15ź LOWER-EXTREMITY SUPPORT OKD-10

ź AM-OSK-O/2Rź AM-OSK-ZJ/2Rź AM-OSK-Z/1ź AM-OSK-O/1ź AM-OSK-Z/2ź AM-OSK-Z/2-02ź AM-OSK-O/2ź AM-OSK-ZJ/2ź AM-OSK-ZL/1Rź AM-OSK-OL/1Rź AM-OSK-ZL/2Rź AM-OSK-ZL/2R-02ź AM-OSK-OL/2Rź AM-OSK-ZL/2ź AM-OSK-ZL/2-02ź AM-OSK-OL/2ź AM-OSK-Z/2RAź AM-OSK-Z/2RA-02ź AM-OSK-O/2RAź AM-OSK-ZJ/2RAź AS-SKL/Fź AM-OSK-ZL/2RAź AM-OSK-ZL/2RA-02ź AM-OSK-OL/2RAź AM-OSK-OL/1ź AM-OSK-ZL/1ź LOWER-EXTREMITY SUPPORT AM-OP-03ź LOWER-EXTREMITY SUPPORT AM-OP-04ź LOWER-EXTREMITY SUPPORT AM-OP-05ź LOWER-EXTREMITY SUPPORT AM-SB/1Rź LOWER-EXTREMITY SUPPORT 4ARMY-SK-01ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-02ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-03ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-04ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-05ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-06ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-07ź LOWER-EXTREMITY SUPPORT 4ARMY-SK-08

Company owner

Sławomir Wroński

Głogów Małopolski., 04.03.2019

52/D/EN/3page 4/4

MODEL:

ź LOWER-EXTREMITY SUPPORT OKD-11ź LOWER-EXTREMITY SUPPORT OKD-12ź LOWER-EXTREMITY SUPPORT OKD-13ź LOWER-EXTREMITY SUPPORT OKD-14ź LOWER-EXTREMITY SUPPORT OKD-15ź LOWER-EXTREMITY SUPPORT OKD-16ź LOWER-EXTREMITY SUPPORT OKD-17ź LOWER-EXTREMITY SUPPORT OKD-18ź LOWER-EXTREMITY SUPPORT OKD-19ź LOWER-EXTREMITY SUPPORT OKD-20ź LOWER-EXTREMITY SUPPORT OKD-21ź LOWER-EXTREMITY SUPPORT OKD-22ź LOWER-EXTREMITY SUPPORT OKD-23ź LOWER-EXTREMITY SUPPORT OKD-24ź LOWER-EXTREMITY SUPPORT OKD-25ź LOWER-EXTREMITY SUPPORT OKD-26ź LOWER-EXTREMITY SUPPORT OKD-27ź LOWER-EXTREMITY SUPPORT OKD-28ź LOWER-EXTREMITY SUPPORT OKD-29ź LOWER-EXTREMITY SUPPORT OKD-30ź LOWER-EXTREMITY SUPPORT AM-OSS-21ź LOWER-EXTREMITY SUPPORT AM-OSS-22ź LOWER-EXTREMITY SUPPORT AM-OSS-23ź LOWER-EXTREMITY SUPPORT AM-OSS-24ź LOWER-EXTREMITY SUPPORT AM-OSS-25ź LOWER-EXTREMITY SUPPORT AM-OSS-26ź LOWER-EXTREMITY SUPPORT AM-OSS-27ź LOWER-EXTREMITY SUPPORT AM-OSS-28ź LOWER-EXTREMITY SUPPORT AM-OSS-29ź LOWER-EXTREMITY SUPPORT AM-OSS-30ź LOWER-EXTREMITY SUPPORT AM-SB-06ź LOWER-EXTREMITY SUPPORT AM-SB-07ź LOWER-EXTREMITY SUPPORT AM-SB-08ź LOWER-EXTREMITY SUPPORT AM-SB-09ź LOWER-EXTREMITY SUPPORT AM-SB-10ź LOWER-EXTREMITY SUPPORT AS-PU-02ź LOWER-EXTREMITY SUPPORT AS-PU-03

ź LOWER-EXTREMITY SUPPORT AS-PU-04ź LOWER-EXTREMITY SUPPORT AS-PU-05ź LOWER-EXTREMITY SUPPORT AS-PU-06ź LOWER-EXTREMITY SUPPORT AS-U-01ź LOWER-EXTREMITY SUPPORT AS-U-02ź LOWER-EXTREMITY SUPPORT AS-U-03ź LOWER-EXTREMITY SUPPORT AS-U-04ź LOWER-EXTREMITY SUPPORT AS-U-05ź LOWER-EXTREMITY SUPPORT AS-U-06ź KNEE BRACE UNDERSLEEVE RW-ProFitź KNEE BRACE UNDERSLEEVE RW-Sportź KNEE BRACE UNDERSLEEVE RW-PowerFitź KNEE BRACE UNDERSLEEVE RW-01ź KNEE BRACE UNDERSLEEVE RW-02ź KNEE BRACE UNDERSLEEVE RW-03ź FIX-KD-01ź FIX-KD-02ź FIX-KD-03ź FIX-KD-04ź FIX-KD-05ź FIX-KD-06ź FIX-KD-07ź FIX-KD-08ź FIX-KD-09ź FIX-KD-10ź FIX-KD-11ź FIX-KD-12ź FIX-KD-13ź FIX-KD-14ź FIX-KD-15ź FIX-KD-16ź FIX-KD-17ź FIX-KD-18ź FIX-KD-19ź FIX-KD-20

PRODUCT:

APPENDIX NO. 1TO DECLARATION OF CONFORMITY NO. 52/D/EN/3

LOWER-EXTREMITY SUPPORT

Company owner

Sławomir Wroński

Głogów Małopolski., 04.03.2019