510(k) K193275

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

K193275 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 April 11, 2020. 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
April 11, 2020
Date Received
November 26, 2019
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