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Air Compression Therapy Device, model: ST-502

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213745

by Shenzhen Future Electronic Co., Ltd.

Identifiers

510(k) Number
K213745 FDA 510(k)
FDA Product Code
IRP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5650 FDA 510(k)
Regulation Number
890.5650 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Air Compression Therapy Device, model: ST-502, is a powered inflatable tube massager. It is classified as a class 2 device under the regulation number 890.5650, and its medical specialty is Physical Medicine.

The device is supplied by Shenzhen Future Electronic Co., Ltd. and has received FDA 510(k) clearance under the approval number K213745. It is a substantially equivalent device, and its clearance type is traditional. The device is used in the field of physical medicine.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Air Compression Therapy Device, model: ST-502 (K213745) — FDA 510 (k ..., K213745 FDA 510 (k) - Air Compression Therapy Device, Air Compression Therapy Device, model: ST-502 - FDA 510(k) K213745, Air Compression Therapy Device, model: ST-502 - BEUDAMED

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Future Electronic Co., Ltd.

Sources (1)

  • FDA 510(k) K213745 24 fields · synced Sep 21, 2026