Easy Med TN-28 C

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

510(k) Number

K040253 ↗

FDA Product Code

GZJ

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Easystim Nms-28

  Class II

  FDA 510(k) K050921 Active Cleared 12 Dec 2005

• SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator

  Class II

  FDA 510(k) K153045 Active Cleared 13 May 2016

• SmartTENS

  Class II

  FDA 510(k) K143430 Active Cleared 29 May 2015

• What is the EASY MED TN-28 C used for?

  The EASY MED TN-28 C is a medical device classified under product code GZJ, specifically intended for use in neurology applications. It was designed to meet the needs of neurological procedures and treatments.

• Is the EASY MED TN-28 C single-use or reusable?

  The EASY MED TN-28 C is supplied as either a single-use or reusable product, though the specific details regarding which models are single-use versus reusable are not provided in the available data.

• What regulatory approvals does the EASY MED TN-28 C have?

  The EASY MED TN-28 C received FDA 510(k) clearance with the K number K040253 on April 8, 2004, following a determination of substantial equivalence. It was reviewed by the Neurology advisory committee.

• Who manufactures the EASY MED TN-28 C?

  The EASY MED TN-28 C is manufactured by Easy Med Instrument Co., Ltd., located at 2/F-3/F, #2 Beihai Da Rd., Lunjiao, Shunde, Guangdong, China, with postal code 528303.