Clearance Summary
DR. LIBERSON'S MICROPULSE NEUROMUSCULAR TRANS STIM received FDA 510(k) clearance under submission number K912342, sponsored by Amer Inst of Electrodiagnosis/Electrotherapy, Inc.. 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 1991-12-09.
- Submission: K912342
- Applicant / Sponsor: Amer Inst of Electrodiagnosis/Electrotherapy, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1991-12-09
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.