Ballancer Gold, 1212
by Mego Afek AC, Ltd. 510(k)
Active
510(k) K190015
Overview
The Ballancer Gold, 1212 is a powered inflatable tube massager used in physical medicine. It is designed to provide therapeutic massage through controlled inflation and deflation of the tube.
The device is supplied by Mego Afek AC, Ltd. and has received FDA 510(k) clearance as substantially equivalent. It is a Class II medical device with product code IRP, intended for use in physical medicine settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190015 | Date25 Mar 2019 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IRP
- FDA applicant
- Mego Afek AC , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5650
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Mego Afek AC, Ltd.
Questions
What is the Ballancer Gold 1212 used for?
The Ballancer Gold 1212 is a powered inflatable tube massager designed for therapeutic massage in physical medicine settings. It provides controlled inflation and deflation of the tube to deliver therapeutic massage treatments.
How is the Ballancer Gold 1212 supplied?
The Ballancer Gold 1212 is supplied by Mego Afek AC, Ltd. It is a Class II medical device with product code IRP, intended for use in physical medicine settings.
What is the regulatory status of the Ballancer Gold 1212?
The Ballancer Gold 1212 has received FDA 510(k) clearance as substantially equivalent. It was cleared on March 25, 2019, with K number K190015, and is classified under product code IRP.
Is the Ballancer Gold 1212 reusable or single-use?
The device data does not specify whether the Ballancer Gold 1212 is designed for single-use or multiple reuse. This information would need to be obtained directly from the manufacturer or product documentation.