Product – Wetling W200

The Wetling W200 is the only approved medical device that provides Wireless Micro Current Stimulation (WMCS) for wound and tissue healing.

Intended Purpose

The Wetling W200 device is intended to be used in professional health care environments for delivery of Wireless Micro Current Stimulation (WMCS) to patients. Without direct contact to the injured tissue, WMCS promotes and accelerates wound and tissue healing by attracting the cells of repair, changing cell membrane permeability, enhancing cellular secretion through cell membranes, and orienting cell structures through the bioelectrical process of electrotaxis.

Indications for Use

The Wetling W200 device is suitable for WMCS treatment of most types of wounds and injuries, both chronic and acute:

  •  Pressure ulcers
  •  Venous leg ulcers
  •  Arterial ulcers
  •  Diabetic foot ulcers
  •  Burns; 1st , 2nd, and 3rd degree
  •  Surgical wounds
  •  Traumatic wounds
  •  Soft tissue injuries

Main Benefits

The Wetling W200 device has the following main benefits as compared to conventional wound care:

  •  Accelerated healing / shorter healing times
  •  Fast pain relief / reduced need of pain medication
  •  Improved patient comfort
  •  Reduced risk of infections
  •  Easy to use
  •  Significant cost savings

Contraindications

Do not use the Wetling W200 if:

  •  The patient is pregnant or nursing.
  •  The patient has a pacemaker or other implanted electrical device(s).
  •  The patient has a malignancy close to the wound.
  •  The patient suffers from epilepsy or other neuroexcitatory conditions.

 

Side Effects

Light itching, tingling and/or redness may occur during and/or after the treatment.

Clinical Evidence

The performance, efficacy and safety of the Wetling W200 have been validated in various clinical trials, case reports and case studies. The clinical evidence is summarized in an independently authored Clinical Evaluation Report (CER), based on 127 articles and other publications.

 

The CER is available upon request to health care practitioners and other specialists that are interested in delving further into the scientific evidence on which this groundbreaking new product is based.

Certifications
The Wetling W200 is a CE marked device and currently has regulatory approvals and registrations in the following markets:
Europe MDD 93/42/EEC Class IIa
Australia ARTG Class IIa
Singapore HSA Class B
Malaysia MDA Class B
Indonesia MOH Class B
New Zealand WAND Class IIa
Thailand Thai FDA Class 2

In addition, the Wetling company is certified as per ISO 13485:2016 for the Production, distribution sales and service of active medical devices for wound healing by TÜV SÜD in Munich, Germany.