Users Manual

FDA
A review of the Code of Federal Regulations Subchapter Title 21 H-Medical Device, Part 80 Physical
Medical Devices, Subpart F Physical Medicine Therapeutic Devices indicates that this device meets
similar standards to Sec. 890.5975 Therapeutic Vibrator and is a Class 1 device. The device is exempt
from the premarket notification procedures. As such there are no known risks to the subjects beyond
those associated with using similar Class 1 devices such as therapeutic vibrators or a soft knee braces.
FCC
Changes or modifications not expressly approved by the party responsible for compliance could void the
user’s authority to operate the equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
NOTE: This equipment has been tested and found to comply with the limits for a Class A
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with the instruction manual, may cause
harmful interference to radio communications. Operation of this equipment in a residential
area is likely to cause harmful interference in which case the user will be required to correct
the interference at his own expense.
IC
CAN ICES-3(A)/NMB-3(A)
This device complies with ISED Canada license-exempt RSS standard(s). Operation is subject to the
following two conditions:
1. This device may not cause interference, and
2. This device must accept any interference, including interference that may cause undesired operation
of the device.
Le présent appareil est conforme aux CNR d’ISDE Canada applicables aux appareils radio exempts de
licence. L’exploitation est autorisée aux deux conditions suivantes :
1. l’appareil ne doit pas produire de brouillage;
2. l’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en
compromettre le fonctionnement.