Jul 9, 2022
iRelaxBot has gotten FDA registration formally under Medical Device.
Registration Number: 3022866854
Proprietary Name: iRelaxBot
Classification Name: MASSAGER, THERAPEUTIC, ELECTRIC
Regulation Number: 890.5660
Medical Specialty: Physical Medicine
Registered Establishment Name: DJB NETWORK LLC
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
PART 890 -- PHYSICAL MEDICINE DEVICES
Subpart F - Physical Medicine Therapeutic Devices
Sec. 890.5660 Therapeutic massager.
(a) Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]