ST-302 Infrarex

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

510(k) Number

K990233 ↗

FDA Product Code

ILY

Device Class

Class II

Regulation

21 CFR Part 890.5500

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Micro 100, 200, 300, & 400 Tens

  Class II

  FDA 510(k) K923298 Active Cleared 13 Oct 1992

• SD-605 SD II Program

  Class II

  FDA 510(k) K923935 Active Cleared 15 Oct 1992

• Bio SDP (Saturn SD, GLC-III SD, Stat-SD)

  Class II

  FDA 510(k) K934051 Active Cleared 11 Jul 1994

• It-727 (Also Known As It-610, It-600 and Dynaphor II

  Class II

  FDA 510(k) K946337 Active Cleared 20 Dec 1995

• Sd-610M(Also Known As Standard Tens, Sd-609M, Sd-611M, Glc-I Standard)

  Class II

  FDA 510(k) K963729 Active Cleared 13 Feb 1997

• IF400

  Class II

  FDA 510(k) K930535 Active Cleared 14 Jun 1994

See all devices from Skylark Device Co., Ltd. →

• What is the primary function of the ST-302 Infrarex?

  The ST-302 Infrarex is a therapeutic device that emits infrared radiation to a specific target area of the body. This process provides localized heat, which is intended to temporarily increase local blood circulation and help alleviate minor muscle and joint aches and pains.

• Where can the ST-302 Infrarex be used?

  This device is designed for versatility and is intended for use in both professional clinical environments and home settings, allowing for consistent therapeutic access in various locations.

• What is the regulatory status of this device?

  The ST-302 Infrarex has received FDA 510(k) clearance under the reference number K990233. This indicates that the device was reviewed and found to be substantially equivalent to legally marketed predicate devices.