tested — not confirmed— Real instrument/substrate; the diagnostic or therapeutic interpretation failed testing; a correct reinterpretation remains open (§0.1-B).
The cleanest 'tested and failed' entry in the set: a blinded randomized trial exists and is negative, and enforcement action followed the marketing. These devices are passive — no energy is delivered — so family assignment is by claim, since there is no carrier to file them under.
Origin & lineage
Consumer wellness (Q-Ray, Power Balance, and similar).
Claimed mechanism
Passive bracelets claimed to relieve pain or improve balance, strength and flexibility via magnets, 'ionisation' or a 'hologram'.
Plausibility
Implausible / contradicts physics — no energy is delivered.
Evidence — grade F
TESTED and not confirmed. Bratton et al., Mayo Clin Proc 2002;77(11):1164–8 (n=305+305) found no benefit over placebo. Enforcement followed: the FTC won a false-advertising judgment against Q-Ray (2006; Seventh Circuit affirmed 2008; ~$16m profits surrendered, redress to ~248,931 buyers in 2011); in Australia (2010) the Power Balance distributor conceded no credible basis for its claims and offered refunds.
Market
Makers: Q-Ray; Power Balance; many imitators. Models: Ionised / magnetic / hologram bracelets. Price: ~$20–200.
Kernel — keep vs set aside
Keep — real substrate
Nothing active — the devices are passive; there is no delivered energy to keep.
Set aside — claim
Blinded testing showed no benefit over placebo, and courts found no property distinguishing the bracelets from ordinary ones of the same metals.
Regulatory status by jurisdiction
Registration or clearance is a market-access fact, never proof of efficacy.
US — FDA
Not a supported medical claim; FTC false-advertising judgment (Q-Ray).