AXIOM-HVG
by Axiom Manufacturing 510(k)
Active
510(k) K955146
Overview
The AXIOM-HVG is a Stimulator, Muscle, Powered device classified under product code IPF. It is a Class II medical device subject to special controls.
The device received FDA 510(k) clearance K955146 on May 17, 1996, following a traditional review process. It was determined to be substantially equivalent for some indications and reviewed by the Physical Medicine advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK955146 | Date17 May 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IPF
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory Committee
- Physical Medicine
- FDA Decision
- SN
Other devices from Axiom Manufacturing
Questions
What is the AXIOM-HVG used for?
The AXIOM-HVG is a powered muscle stimulator classified under product code IPF as a Class II medical device. It received FDA 510(k) clearance for being substantially equivalent for some indications, as determined by review from the Physical Medicine advisory committee.
How was the AXIOM-HVG cleared for market?
The AXIOM-HVG received FDA 510(k) clearance through a traditional review process. It was found substantially equivalent for some indications after evaluation, with clearance granted on May 17, 1996, under clearance type Traditional and decision code SN.
Who manufactures the AXIOM-HVG and where is it based?
The AXIOM-HVG is manufactured by Axiom Manufacturing, located at 717 Lingo Dr. #202, Richardson, TX 75081, United States. The applicant listed in the FDA submission is Axiom Manufacturing, with Charles Osborne as the contact.