Biostim-HV
510(k) K946298
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK946298 | Date11 May 1995 | 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- Withdrawn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, 1 Oct 2026
The Biostim-HV is a Physical Medicine Device (21 CFR 890.5850) designed for high-voltage electrical stimulation therapy. It delivers controlled electrical impulses to promote muscle stimulation, pain relief, or tissue healing through transcutaneous electrical nerve stimulation (TENS) or neuromuscular electrical stimulation (NMES). The device is classified under product code IPF and is intended for clinical use in physical therapy settings.
The Biostim-HV is supplied as a reusable medical device and requires proper maintenance per manufacturer guidelines. It is not sterile and is intended for use in non-MRI environments due to its electrical components. The device was cleared under a Traditional 510(k) pathway (K946298) and is regulated under FDA compliance for physical medicine applications. Storage and handling follow standard electrical medical device protocols to ensure safety and functionality.
Other devices from Progressive Concepts, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Biostim-HV used for in clinical settings?
The Biostim-HV is a high-voltage electrical stimulation device designed for transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). It delivers controlled electrical impulses to promote muscle stimulation, alleviate pain, or aid tissue healing. Clinicians primarily use it in physical therapy settings to support rehabilitation and recovery processes.
Is the Biostim-HV a single-use or reusable device?
The Biostim-HV is a reusable medical device. It is intended for repeated use in clinical environments, provided it undergoes proper maintenance and cleaning as outlined in the manufacturer’s guidelines to ensure safety and functionality.
Does the Biostim-HV require sterilization before use?
No, the Biostim-HV is not sterile and does not require sterilization. It is designed for non-sterile clinical applications where electrical stimulation is applied externally through electrodes. Sterility is not applicable due to its reusable nature and intended use in physical therapy.
Can the Biostim-HV be used in MRI environments?
No, the Biostim-HV is not intended for use in MRI environments. Its electrical components make it incompatible with magnetic resonance imaging due to potential interference or safety risks associated with electromagnetic fields.
What regulatory pathway was followed for the Biostim-HV’s clearance?
The Biostim-HV was cleared under the FDA’s Traditional 510(k) pathway (K946298) and is classified under product code IPF for physical medicine devices. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA regulations for high-voltage electrical stimulation therapy.