I'll be going in for mine. Driver's door only rattles, at about 4-5" down. If I know I'm gonna hit bumps, I put it all the way up or at least 1/2 way down. I have had a bad rattle with other windows down, and driver's only partially down in high winds as well.
Then I would question the surgeon as much as the manufacturer.
FDA recorde all failures (complaints) and botched surgeries. Unless your wife was the first use, the failure rate is known. There are surgeo that ignore that data at the peril of the patient
My wife drives a JK. When I met her she had a ‘78 4wd Hi lux. We’ve always wheeled, but only my trucks - S10, ram, F250, H2.
she will not wheel hers, even tho she’s only had 4wd because “she wants to sit higher than a car for safety” 😂
After the Tn Rodeo, she wants to wheel again, after a...
"and without any of the above process, on the basis of it being "substantially similar" to a previous product that was already approved."
Not possible, legaly.
If it was a "Substantially similar" device, Special 510(K) only allows for the original manufacturer to make modifications to it's own...
None of the shortcuts you cited are unsafe. Just cost cutting and cheap.
I didn't say the customs were unsafe. Unconventional, perhaps, but still meet all risk requirements.
Medical devices fall into 3 classes, based on risk, invasiveness and potential impact on patient health.
Depending on...
That is not engineering. That is cost cutting. Trust me, engineers are over ridden daily on their decisions and directives based on cost.
Engineering is always driven my marketing to a certain extent.
We make a number medical device specials, because a certain surgeon or surgical group wants an...
We make mostly devices, but recalls are real. And so are the consequences if one of our devices fail during surgery.
The metal on metal hip fiasco for Stryker, Biomet, Wright (Now Stryker), DePuy and Zimmer went into multiple 10's of billions.
I think people's hair would catch fire if they knew what we sell surgical implants and devices for.
But after validated processes, capability studies, Ppk Cpk requirements, FDA regulations, etc, the end profit margins are not super high.
I am a firm believer in working equipment so that fluids fluid, seals seal, etc.. this keeps things from drying out and hardening.
simple treks off road, doesn’t need to be extreme. just some loose traction spots.
i need to remind my wife of this as she is a mall queen in her JK
As I learnt at the off rodeo, trail control is best used during descents. It worked wonderfully in Tn rocks mud and trees, with braking engaging quicker than me. I want more throttle control ascending than trail control offers.
So skinny jeans just showed he didn’t know what to use when.
Im about 7 hrs west. and I need skids.
But I would love to once I can get the skids done. but once done, ima book a long weekend/week. I absolutely love your side of the state. Thank you for the invite!
If there were more medical device manufacturers out there, I’d move in a heartbeat...
Not everybody wants to (or can) own.
My wife's mom is a first gen American from Mexico. Since she has advanced dementia, my wife manages her 19 properties in Ca. In one house, located in SE LA (Lincoln Heights, the ghetto), an older illegal immigrant gentleman has rented that same house for...