Clearance Summary
DERMAPOINTS MODEL 200 THERAPEUTIC MASSAGER received FDA 510(k) clearance under submission number K881081, sponsored by Ferguson Medical. 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 1988-07-21.
- Submission: K881081
- Applicant / Sponsor: Ferguson Medical
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1988-07-21
Classification & Regulation
This clearance is catalogued under FDA product code LYG and 21 CFR 890.5660, within the Physical Medicine review panel as a Class I device.