510(k) K810513

ELECTRODYN CII-INTERFERENTIAL MUSCLE by Nemectron Medical, Inc. — Product Code IPF

K810513 is an FDA 510(k) premarket notification submitted by Nemectron Medical, Inc. for the device "ELECTRODYN CII-INTERFERENTIAL MUSCLE". The FDA issued a decision of Substantially Equivalent on May 11, 1981. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Nemectron Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1981
Date Received
February 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type