510(k) K944935

DYNATRON 250 by Dynatronics Corp. — Product Code IPF

K944935 is an FDA 510(k) premarket notification submitted by Dynatronics Corp. for the device "DYNATRON 250". The FDA issued a decision of SN on June 22, 1995. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Dynatronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
June 22, 1995
Date Received
October 6, 1994
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