Holter Prep Kit
Holter prep kit Each prep kit contains: 1 razor 1 alcohol pad 1 AA battery 1 skin scrubby 1 page of 5 wet gel electrodes 1 patient diary
Shave Prep Kit
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong.
What Is This Device?
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
What Is FDA Product Code OJW?
Shave Prep Kit is FDA product code OJW, Class 2, 21 CFR 878.4370.
How Does It Reach the US Market?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.