A tinnitus masker is an (special electronic device controls). intended to generate The special noise of sufficient controls for intensity and bandwidth KLW this device 41 Tinnitus Class 2 874.3400 to mask ringing in the are (see masker ears or internal head 874.3400) noises. Because the device is able to mask 510 k internal noises, it is also required used as an aid in Mobile Medical Application (Mobile Medical App) mobile app that meets the definition of APP device in section 201(h) An APP that might have Classification (That does not Regulation of the Federal Food, diagnostic purpose and follows the 41. drive or follows Drug, and Cosmetic Act doesn’t include a RC or has a device influence the device (FD&C Act)4; and either function that directly device) is intended: influences the device. to be used as an accessory to a regulated medical device; Mobile Medical An APP including a Remote APP Application (Mobile Classification Regulation Control that changes a (that drives or Medical App) 42. follows the follows program setting or directly influences the mobile app that device device influences the SW parameters device) meets the definition of of the device device in section 201(h)
41 Tinnitus masker Class 2 874.3400 A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in KLW (special controls). The special controls for this device are (see 874.3400) 510 k required 41. APP (That does not drive or influence the device) Classification follows the device Regulation follows device Mobile Medical Application (Mobile Medical App) mobile app that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)4; and either is intended: to be used as an accessory to a regulated medical device; An APP that might have diagnostic purpose and doesn’t include a RC or has a function that directly influences the device. 42. APP (that drives or influences the device) Classification follows the device Regulation follows device Mobile Medical Application (Mobile Medical App) mobile app that meets the definition of device in section 201(h) An APP including a Remote Control that changes a program setting or directly influences the SW parameters of the device
Classification-Document-v14.4.docx