Clearance Summary
COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER received FDA 510(k) clearance under submission number K955160, sponsored by Everapex Design & Marketing Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1996-02-08.
- Submission: K955160
- Applicant / Sponsor: Everapex Design & Marketing Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5975
- Decision date: 1996-02-08
Classification & Regulation
This clearance is catalogued under FDA product code IRO and 21 CFR 890.5975, within the Physical Medicine review panel as a Class I device.