Cleared Traditional

Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507)

K251662 · Shenzhen Future Electronic Co., Ltd. · Physical Medicine

Nov 2025

Decision

167d

Days

Class 2

Risk

About This 510(k) Submission

K251662 is an FDA 510(k) clearance for the Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507), a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Shenzhen Future Electronic Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 13, 2025, 167 days after receiving the submission on May 30, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number	K251662 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2025
Decision Date	November 13, 2025
Days to Decision	167 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF