510(k) K020749

DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS by Everyway Medical Instruments Co.,Ltd — Product Code GZJ

K020749 is an FDA 510(k) premarket notification submitted by Everyway Medical Instruments Co.,Ltd for the device "DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS". The FDA issued a decision of Substantially Equivalent on Oct 31, 2002. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. 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, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type
510(k)

Source: FDA 510(k) database entry for K020749. Report a data issue: hello@regdatalab.com.