Relieves Pain Naturally and Accelerates Recovery

Model: LX 1000
EAN: 4897080 000008

FDA Listed Device Number: D316762

 

PBMFLEX® flexible Phototherapeutic Device alleviates back pain, neck discomfort, joint aches and muscle soreness. The device is developed with photobiomodulation (PBM) or low-level light therapy (LLLT) technology to maintain health – Uses the body’s natural processes to heal.

HKD4,160.00 HKD3,130.00
Product Features

Product Features

 

PBMFLEX® Phototherapeutic Device LX 1000 alleviates back pain, neck discomfort, joint aches and muscle soreness.

Photobiomodulation (PBM) or low-level light therapy (LLLT) technology to maintain health - Uses the body’s natural processes to speed up recovery.

880 nm monochromatic LED light stimulates the damaged cells repairing them to their natural state.

 

Symptoms to treat

Pain or aches in joints caused by rheumatoid arthritis (RA) and osteoarthritis (OA), muscle aches and soreness caused by inflammation.

* It is important to note that PBMFLEX HEALTH recommends that you always consult a specialist or your primary physician to be correctly diagnosed.

 

Suitable for the most part of the body

PBMFLEX® flexible Phototherapeutic Device is suitable to be attached on lower back, neck, shoulder, elbow, wrist, knee, popliteus and ankle, etc. to treat pain or stiffness.

 

Simple and convenient to use

User friendly controller offers your daily treatment simple and convenient. You can use PBMFLEX® Phototherapeutic Device at home and work, when watching TV or sleeping or sitting.

 

Flexible and durable material

PBMFLEX® Phototherapeutic Device is made of flexible and durable material, hygienic silicone, with innovative design for the most comfort of use. The Device is designed to be attached onto the skin and held against the body with a soft strap.

 

Waterproof and easy clean

PBMFLEX® Phototherapeutic Device is waterproof and can be cleaned with damp cloth, with water and the most popular household cleaners in the market, can also be sterilized with the most popular household disinfectants in the market.

Specifications

Specifications

 

Device Specifications

Photon Wavelength:

 

880 nm

Photon Energy:

 

1.8 mW/cm2 (at Standard energy level)
2.7 mW/cm2 (at High energy level)

Classification:

 

Risk Group 1

LED Emitting Area:

 

22.7 cm x 9.8 cm

Pad Weight:

 

175 g

Pad Material:

 

Silicone

Device Input:

 

10V DC, 1.5 A

Power Supply Class:

 

Class II

Power Supply Input:

 

100 – 240V AC, 50 – 60 Hz

Power Cord Length:

 

2 m

Velcro® Straps:

 

1 for waist size 28” – 42”
1 for waist size 40” – 65”
Nylon polyester material

Operating Environment:

 

Temperature 10 °C – 35 °C
Relative humidity 30% – 90%

Safety Testing and Certifications

Safety Testing and Certifications

 

Tests Passed and Standards Met

 

– EN 60601-1:2006+A1:2013
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance


– EN 60601-1-11:2010
Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment


– EN 60601-1-2-57:2011
Medical electrical equipment – Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use


– EN 60601-1-6:2010+A1:2015
Medical electrical equipment – Part 1-6: General requirements for safety – Collateral Standard: Usability


– EN 62366:2008+A1:2015
Medical devices – Application of usability engineering to medical devices


– EN 60601-1-2:2007
Medical electrical equipment – Part 1-2: General Requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility (EMC)


– CFR 47 FCC PART 15 SUBPART B:2014
Electromagnetic Interference (EMI)


– EN ISO 10993-1:2009/AC:2010
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process


– EN ISO 10993-5:2009
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity


– EN ISO 10993-10:2013
Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization


– EN 62471-5:2008
Photobiological safety of lamps and lamp systems

 

FDA Registration and Listing

Establishment Registration Number: 3014331305
Listed Device Number: D316762

 

FCC Certification

Certificate issued by SGS-CSTC
In conformity with CFR 47 FCC PART 15 SUBPART B:2014

 

CB Certification

Certificate issued by SGS Fimko
In conformity with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-11:2010, IEC 60601-2-57:2011, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013

 

Certifications in Progress

ISO 13485 Quality Management System
Medical CE

Instruction Manual

Instruction Manual

 


Instruction Manual
For
Phototherapeutic Device
LX 1000

(click to download)