Impulse HVG
510(k) K970847
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970847 | Date10 Sep 1997 | 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- Withdrawn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 Impulse HVG is a Powered Muscle Stimulator, classified under FDA product code IPF (Stimulator, Muscle, Powered) and intended for physical medicine applications. This device delivers electrical impulses to stimulate skeletal muscles, aiding in rehabilitation, muscle strengthening, or neuromuscular re-education. Its design is tailored for clinical use in physical therapy settings, where precise control of stimulation parameters is required. The device operates under the regulatory framework for Class II medical devices, ensuring compliance with safety and performance standards.
The Impulse HVG is supplied as a reusable, non-sterile medical device, intended for use in controlled clinical environments such as physical therapy clinics or rehabilitation centers. It is regulated under FDA 510(k) clearance (K970847), with a decision date of September 10, 1997, and falls under the Physical Medicine advisory committee. No specific MRI safety classification or sterility requirements are noted in the regulatory submission. Storage and handling follow standard electrical medical device protocols to maintain functionality and safety.
Other devices from Armstrong Industries, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Impulse HVG used for in clinical settings?
The Impulse HVG is a powered muscle stimulator intended for physical medicine applications. It delivers controlled electrical impulses to stimulate skeletal muscles, supporting rehabilitation, muscle strengthening, and neuromuscular re-education in clinical environments like physical therapy clinics or rehabilitation centers.
Is the Impulse HVG a single-use or reusable device?
The Impulse HVG is designed as a reusable medical device. It is not intended for single-use and is meant to be used repeatedly in controlled clinical settings, provided it is maintained according to standard electrical medical device protocols.
What regulatory pathway does the Impulse HVG follow?
The Impulse HVG is classified under FDA product code IPF (Stimulator, Muscle, Powered) and is regulated as a Class II medical device. It received FDA 510(k) clearance (K970847) on September 10, 1997, under the Physical Medicine advisory committee, demonstrating compliance with safety and performance standards for powered muscle stimulators.
Does the Impulse HVG require sterility for clinical use?
No, the Impulse HVG is supplied as a non-sterile device. It is intended for use in controlled clinical environments where sterility is not a requirement for the device itself, though standard hygiene practices for electrical medical equipment should still be followed.
How should the Impulse HVG be stored and handled?
The Impulse HVG should be stored and handled according to standard protocols for electrical medical devices. This includes protecting it from physical damage, moisture, and extreme temperatures to ensure its functionality and safety. Regular maintenance and inspections are recommended to uphold performance standards.