OW100S

Organization name

MTS Medical AG (Aktiengesellschaft)

SRN

DE-MF-000005447

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  • Do not use the device in patients with pacemakers or implantable defibrillators. • Do not use the device in patients who are using devices which are sensitive to electromagnetic radiation. • Do not use the device in confirmed or suspected pregnancy. • Do not use the device for the treatment of vertebrae, skull bones and ribs. • Do not adjust the therapy focus on internal organs (especially lungs). • Do not use the device for the treatment of patients with tumors. • Do not use the device for the treatment of patients with coagulation disorders or if the patient currently receives anticoagulants. • Do not adjust the therapy focus on large nerves. • Do not use the device for the treatment of patients younger than 18 years or of patients with open epiphyseal plates. • Do not adjust the therapy focus on large vessels. • Do not use the device for extracorporeal shock wave lithotripsy.

Primary placement in Germany; available across 5 countries total.

Trade name

OW100S

UDI-DI code

04260484571229

Basic UDI-DI

426048457OW100OW100SZB

Reference / catalog number

1000019

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The OW100S is a non-invasive shock wave medical device under the model OW100S, which is used together with its accessories for orthopaedic, dermatological & urological indications

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z12139001SHOCK WAVE THERAPY EQUIPMENT

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification