FDA 510(k) Premarket Notification K242140: Air Compression Leg Massager (K-705)

Submission Details & Decision

Normalized public record details for 510(k) notification K242140.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K242140

Applicant / Sponsor

Jiale Health Technology Shenzhen Co., Ltd.

Device Name

Air Compression Leg Massager (K-705)

Product Code

IRP

Decision Date

2025-03-17

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Physical Medicine (PM)

Clearance Type

Traditional

Third Party Flag

Date Received

2024-07-22

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