XH-1 Neuromuscular Stimulator
by California Medical Research Institute
510(k) K950550
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK950550 | Date4 Dec 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The XH-1 Neuromuscular Stimulator is a powered device classified as a neuromuscular electrical stimulator (Nomenclature: IPF). It delivers controlled electrical impulses to stimulate muscle contraction and relaxation, aiding in the management of muscle spasms and improving neuromuscular function.
This device operates using two AA batteries (3 volts) and delivers a fixed-frequency biphasic waveform at 0.9 Hz via electrodes applied to the skin with a water-moistened paper towel. Supplied as a reusable device, it requires no sterilisation and is intended for use in clinical settings such as physical therapy or rehabilitation. Authorised under FDA 510(k) clearance (K950550), it adheres to traditional review standards for physical medicine applications.
Questions
AI-generated answers, 19 Sep 2026
What types of muscle conditions is the XH-1 Neuromuscular Stimulator designed to help manage, and how does it work?
The XH-1 is designed to manage muscle spasms and improve neuromuscular function by delivering controlled electrical impulses to stimulate muscle contraction and relaxation. It uses a fixed-frequency biphasic waveform at 0.9 Hz, applied via electrodes placed on the skin with a water-moistened paper towel. This approach is commonly used in physical therapy or rehabilitation settings to encourage muscle activity and reduce spasticity.
How is the XH-1 Neuromuscular Stimulator powered, and how long can it be used continuously before needing replacement?
The XH-1 operates using two AA batteries (3 volts) and does not specify a runtime duration in the provided data. Since it is a reusable device, users would need to monitor battery life and replace them as needed to maintain continuous operation. The exact runtime would depend on battery capacity and usage frequency.
Is the XH-1 Neuromuscular Stimulator intended for single-use or reusable applications, and what maintenance is required?
The XH-1 is explicitly described as a reusable device and does not require sterilization. Maintenance primarily involves replacing the AA batteries when depleted and ensuring the electrodes and application materials (like water-moistened paper towels) are clean and functional for each use.
What are the key specifications of the XH-1’s electrical output, and how is it applied to the patient?
The device delivers a fixed-frequency biphasic waveform at 0.9 Hz through electrodes applied to the skin. The electrodes are used with a water-moistened paper towel to facilitate conductivity. The waveform and frequency are designed to stimulate muscle contraction and relaxation, aiding in neuromuscular function without requiring invasive procedures.
How was the XH-1 Neuromuscular Stimulator reviewed and approved by the FDA, and what does that mean for clinical use?
The XH-1 was cleared via an FDA 510(k) submission (K950550) under the Traditional Review pathway, determined to be Substantially Equivalent (SESE) to a legally marketed predicate device. This clearance falls under the Physical Medicine advisory committee category (product code IPF), meaning it was evaluated for safety and effectiveness in applications like muscle stimulation for rehabilitation or spasm management in clinical settings.