Clearance Summary
MOSS LIMB LOAD MONITOR LM101-1 received FDA 510(k) clearance under submission number K844202, sponsored by Moss Rehabilation Hospital. 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 1984-11-27.
- Submission: K844202
- Applicant / Sponsor: Moss Rehabilation Hospital
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.1615
- Decision date: 1984-11-27
Classification & Regulation
This clearance is catalogued under FDA product code IKE and 21 CFR 890.1615, within the Physical Medicine review panel as a Class I device.