510(k) K213745

Air Compression Therapy Device, model: ST-502 by Shenzhen Future Electronic Co., Ltd. — Product Code IRP

K213745 is an FDA 510(k) premarket notification submitted by Shenzhen Future Electronic Co., Ltd. for the device "Air Compression Therapy Device, model: ST-502". The FDA issued a decision of Substantially Equivalent on March 31, 2022. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Shenzhen Future Electronic Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2022
Date Received
November 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type