FDA 510(k) Premarket Notification K231440: Combo Electrotherapy Device

Submission Details & Decision

Normalized public record details for 510(k) notification K231440.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K231440

Applicant / Sponsor

Shenzhen Roundwhale Technology Co. , Ltd.

Device Name

Combo Electrotherapy Device

Product Code

IPF

Decision Date

2023-11-03

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Physical Medicine (PM)

Clearance Type

Traditional

Third Party Flag

Date Received

2023-05-18

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