Medical-grade power adapter labeling

#1
I work for a Class II electrical medical device company ("A") and we are looking to get 510k-cleared.
Our device has to be supplied with external power by a medical-grade power adapter.
Currently, the power adapter is only labeled with the name of the OEM ("B") but we want to add our company name onto the label, in addition to B's name.
B told us that they cannot remove their name from the label because of IEC 60601-1 requirements (B sent the power adapter to be tested for compliance with the standard, and we also subject the ME system to IEC 60601-1 as well).
Once the customer buys the medical device, if they lose the power adapter, they can contact us to purchase a replacement.

Here are my questions:
1. Is it okay to change the original power adapter label by just adding "Manufactured for A" and "Manufacturer B" per FDA regulations?
2. Since the labeling will still be done by B and not us, we will not be considered a relabeler, right?
3. Is the power adapter considered an accessory or a component if we intend to sell it to the customer for replacement in the future?

Thank you in advance
 
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#2
1. Is it okay to change the original power adapter label by just adding "Manufactured for A" and "Manufacturer B" per FDA regulations?
It is OKAY to add "Manufactured for A" along with the "Manufactured By B". Just remember to make these roles clear while listing your device at the FDA database.

2. Since the labeling will still be done by B and not us, we will not be considered a relabeler, right?
YES, you are not a relabeler; adding your company name onto the existing label does not make you a relabeler.

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3. Is the power adapter considered an accessory or a component if we intend to sell it to the customer for replacement in the future?
See the definitions from the FDA and make your decision. To me it is supposed to be an Accessory as the Power Adapter is already a finished device.
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#3
It is OKAY to add "Manufactured for A" along with the "Manufactured By B". Just remember to make these roles clear while listing your device at the FDA database.

See the definitions from the FDA and make your decision. To me it is supposed to be an Accessory as the Power Adapter is already a finished device.
Thank you for your reply!

I have additional questions:

The FDA requires that:
(c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, "Manufactured for ___", "Distributed by _____", or any other wording that expresses the facts.

Since an accessory is also a device, the requirement would apply, but not if it is a component, is that right?

We are only adding our company name onto the label out of business considerations.
Because the adapter is not currently listed in the FDA database, if we are treating the power adapter as an accessory and are submitting 510k for our device, we will have to submit An Existing Accessory Request for the power adapter. <Can you confirm if this is correct?
And in this case, will we have to take the regulatory responsibilities for the power adapter?
 
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