If your product is very similar to the vest and is not “new”, it is likely 510K exempt. You really need your regulatory and legal to make that call, not me.
But in my haste in replying yesterday I forgot to say you may need design controls and GMP. Or, you could be exempt from design controls and GMP. Again, that is up to regulatory/legal, but those will also have impact on your quality testing.
For example, one project we have is class 1, 510K and design controls exempt, but is not GMP exempt. We had to write and undertake lengthy QTPs (yes, quality testing protocols), to validate the GMP process. Probably added 6 months before we can actually test the concept on patients. And when we make a change, we will need to change the QTP and validate it for that change. Slow process.