SDS-4I

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K034005 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Skylark Infrared Photon Stimulator, Models, Sd-956IR and Sd-100IR

  Class II

  FDA 510(k) K043306 Active Cleared 6 Jun 2005

• Bio-Stim Kit

  Class II

  FDA 510(k) K050174 Active Cleared 7 Sep 2005

• Conductive Gel for Ultrasound

  Class II

  FDA 510(k) K002832 Active Cleared 6 Aug 2001

• Sd-730 If-Sds, Perfect Pulse If-Sds

  Class II

  FDA 510(k) K992652 Active Cleared 3 Feb 2000

• Skylark Uro Probe

  Class II

  FDA 510(k) K053007 Active Cleared 5 Dec 2005

• What is the SDS-4I device used for?

  The SDS-4I is a powered muscle stimulator device designed for interferential therapy, providing electrical stimulation for therapeutic purposes in physical medicine applications.

• How is the SDS-4I supplied and what is its regulatory status?

  The SDS-4I is supplied by Skylark Device & Systems Co., Ltd. and is authorized under FDA 510(k) number K034005 with product code IPF, classified as a powered muscle stimulator for physical medicine settings.

• Is the SDS-4I a single-use or reusable device?

  The device data does not specify whether the SDS-4I is single-use or reusable, nor does it provide information about sterility or MRI safety characteristics.

• What sizes or models of the SDS-4I are available?

  No information regarding available sizes or models of the SDS-4I is provided in the device data.