Product Line-Combo Stimulator/Sequential Stimulator, Model If-5000

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

510(k) Number

K024036 ↗

FDA Product Code

IPF

FDA applicant

Johari Digital Healthcare , Ltd.

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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See all devices from Johari Digital Healthcare, Ltd. →

• What is the IF-5000 Combo Stimulator/Sequential Stimulator used for?

  The IF-5000 is designed to provide neuromuscular electrical stimulation (NMES) to facilitate muscle contraction, supporting rehabilitation, physical therapy, and functional recovery. It is particularly useful for addressing muscle weakness, atrophy, or impaired mobility in clinical or home settings under prescribed supervision. The device’s micro-computer-controlled system ensures precise, programmable stimulation patterns tailored to therapeutic needs.

• Is the IF-5000 reusable or single-use?

  The IF-5000 is a reusable device, intended for repeated use in clinical settings or by patients under professional guidance. Since it is not sterile, proper cleaning and maintenance between uses are required to ensure hygiene and operational integrity. This design allows for long-term use in therapeutic environments while adhering to manufacturer guidelines for care.

• How should the IF-5000 be stored?

  The IF-5000 must be stored according to the manufacturer’s guidelines to maintain its functionality and ensure patient safety. This includes keeping the device in a clean, dry environment, protected from physical damage or exposure to moisture. Proper storage also involves following any specific instructions provided in the user manual to preserve the device’s operational integrity over time.

• What regulatory clearance does the IF-5000 hold?

  The IF-5000 holds FDA clearance under 510(k) number K024036, classified under Regulation 890.5850 for Physical Medicine applications. This clearance confirms that the device meets FDA standards for safety and effectiveness as a powered muscle stimulator, ensuring its suitability for clinical and home use under prescribed supervision.

• Can the IF-5000 be used at home?

  Yes, the IF-5000 is designed for both clinical and home use, provided it is used under the supervision of a healthcare professional. Its portable and reusable nature makes it suitable for patients to incorporate into their rehabilitation routines at home. However, proper training and adherence to manufacturer guidelines are essential to ensure safe and effective use in a home setting.