The word "reconditioning" does not appear on the FDA "Who Must Register, List and Pay the Fee" page. I haven't had to interact with uses of that term in the device area other than in regard to customs detention where it has an odd legalistic meaning...the term however is used in pharma and food regulation. My understanding is that that term, if used on the device side, would be equivalent to "refurbisher", whatever you think the definition should be of that latter term.
FDA provided a
good discussion of all of the terms we're using here as part of a proposal for regulation of refurbishing and remanufacturing back in 1997. That discussion is formally obsolete, but my expectation would be that the terms-definitions implicitly presented in it are still valid.
It makes sense, because as I stated above (and in several past threads) reconditioning, in the meaning I'm talking about, is not overseen by FDA. It is an intentional policy for at least 10 years now. If you widen your search you will see that this field is subject to sorts of voluntary or semi-voluntary industry codes. Read (broken link removed) for example.
Understanding whether one is a reconditioner is not about identifying FDA regulations or guidance that one must meet; rather, it's about identifying a scope that the FDA intentionally excludes. Whether or not to follow other (voluntary?) frameworks is a separate issue.
The term "Refurbish" is tricky. The way I understand it to be practiced by leading regulators, it requires the following as a minimum:
1. Back purchase of the used device/devices that will serve as a starting point.
2. Stripping the device(s) back to components level.
3. Identifying non-disposable "bad" parts - broken, malfunctioning, worn out etc.
4. Replacing all bad parts with good ones - either new or tested, used ones.
5. Assembling at least one complete device, to the original specs (or updated revision thereof), from "good" - used or new - parts. Disposable elements are all new or reprocessed.
To qualify as refurbishment the process has to involve a complete, systematic disassembly of the device and replacement of all bad parts. This is different from repair (reconditioning?) or service, in which disassembly is normally partial and extends only to necessity / a defined scope. Additionally, repair and service normally don't involve back-purchase and re-sale of the finished (good) device.
Cheers,
Ronen.