510(k) K211094

Nerve and Muscle Stimulator by Shenzhen Xft Medical Limited — Product Code IPF

K211094 is an FDA 510(k) premarket notification submitted by Shenzhen Xft Medical Limited for the device "Nerve and Muscle Stimulator". The FDA issued a decision of Substantially Equivalent on July 8, 2021. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Shenzhen Xft Medical Limited has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2021
Date Received
April 12, 2021
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