Acudata Indicatens Model 5X

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

510(k) Number

K890088 ↗

FDA Product Code

GZJ

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Indicatens Model 4X4 Sp Electrode Stim. Patches

  Class II

  FDA 510(k) K891105 Active Cleared 25 May 1989

• Indicatens 4X4

  Class II

  FDA 510(k) K881708 Active Cleared 11 Aug 1988

• Acudata Indicatens Model 5A

  Class II

  FDA 510(k) K900596 Active Cleared 22 Jun 1990

• Acudata Indicatens Model 5M

  Class II

  FDA 510(k) K890087 Active Cleared 7 Sep 1989

• Indicatens Indicator Electrode Model 2

  Class II

  FDA 510(k) K891107 Active Cleared 25 May 1989

• Acudata Indicatens Model 5XS

  Class II

  FDA 510(k) K900668 Active Cleared 22 Jun 1990

• What is the Acudata Indicatens Model 5X used for?

  The Acudata Indicatens Model 5X is designed for diagnostic and therapeutic electrical stimulation of peripheral nerves. Clinicians use it to assess nerve function, diagnose neurological conditions, or stimulate muscles in controlled clinical settings. Its controlled impulses help evaluate nerve responses and support rehabilitation or therapeutic interventions.

• Is the Acudata Indicatens Model 5X a single-use or reusable device?

  The Model 5X is a reusable medical device. It requires proper calibration and maintenance to ensure accurate and safe operation over repeated clinical uses. Reusability is intended for controlled environments where sterility and functionality can be maintained.

• What regulatory clearance does the Acudata Indicatens Model 5X hold?

  The device holds FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent (SESE). This clearance was determined by the Neurology Advisory Committee and is specific to its use in neurological applications (product code GZJ).

• How should the Acudata Indicatens Model 5X be stored and handled?

  Storage and handling must follow the manufacturer’s guidelines to preserve functionality. The device should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Regular maintenance, including calibration, is essential to ensure reliable performance for diagnostic and therapeutic nerve stimulation.

• Who can use the Acudata Indicatens Model 5X in clinical settings?

  The device is intended for use by trained professionals, such as neurologists or physical therapists, in clinical environments. Its design and functionality require specialized training to operate safely and effectively for nerve assessment or muscle stimulation.