Device, manufacturer, and safety and performance information
1. Information in connection with the Japet.W+ device:
1.a. Device identification:
Model:
Japet.W+
1.b. Manufacturer identification:
Manufacturer:
IAPET MEDICAL DEVICES
147 Pierre Mauroy Avenue
59120 LOOS
france
2. Safety and performance information
Clinical performance of the device
Decompression of intervertebral discs.
Indications
The JAPET.W+ device is indicated for adults suffering from chronic and acute low back pain. The device is intended for the ambulatory distraction of the lumbar spine.
It is recommended to use the device over a T-shirt.
The use of the device is intended for health professionals and/or reference persons who have been trained by JAPET MEDICAL DEVICES® or by a third party authorized to carry out this training.
It is recommended to use the device for sessions of 30 to 60 minutes (2 to 3 times per day).
For use in the workplace, it is recommended to wear the JAPET.W+ device before a painful episode.
Contraindications
This device is contraindicated in the following cases:
- Déficits neurologiques au niveau des racines nerveuses et de la moelle épinière,
- Traitement par neurostimulation implantée,
- Maladie cardiaque ou circulatoire et problèmes respiratoires graves,
- Tumeur ou processus infectieux des vertèbres,
- Ostéoporose symptomatique,
- Antécédents de chirurgie d'arthrodèse,
- Chirurgie d'une hernie discale (< 3 mois),
- Fracture de la colonne dorsolombaire (< 3 mois),
- Fracture des côtes (< 3 mois),
- Lésions cutanées, ecchymoses et élongations du tronc,
- Grossesse (> 4 mois),
- Antécédents de chirurgie de prothèse lombaire.
Contact your doctor if pain occurs or there is an increase in pain while wearing the device.
Possible side effects of the device
Improper positioning of the device or an unsuitable size may cause:
- Inconfort,
- hematomas,
- Irritations,
- Pains.
In case of an adverse reaction not listed and related to the device, please contact JAPET MEDICAL DEVICES®.
Warnings

Messages

Note: If the problem persists, contact Japet Medical
Operating conditions
Temperature: +0°C to +40°C (+32°F to +104°F)
Humidity in the air: 5% to 95%
Atmospheric pressure: 570hPa to 1060hPa
Storage and transport conditions
Temperature: -20°C to +40°C (-4°F to +104°F)
Humidity in the air: 5% to 95%
Atmospheric pressure: 570hPa to 1060hPa