510(k) K020750

DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS by Everyway Medical Instruments Co.,Ltd — Product Code IPF

K020750 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS". The FDA issued a decision of Substantially Equivalent on Oct 31, 2002. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Everyway Medical Instruments Co.,Ltd has 28 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 31, 2002
Date Received
Mar 7, 2002
Clearance Type
Abbreviated
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
510(k)

Source: FDA 510(k) database entry for K020750. Report a data issue: hello@regdatalab.com.