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Axiobionics, LLC

Last updated May 23, 2026

Information

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Device	Model / Reference	Registries	Class	Status
BioTrouser	0	FDA UDI	Class II	Active
LE BioSleeve	8	FDA UDI	Class II	Active
EMPI 300PV Stimulator	0	FDA UDI	Class II	Active
BioGel Velcro Electrode	2	FDA UDI	Class II	Active
UE BioSleeve	4	FDA UDI	Class II	Active
BioGel Velcro Electrode	2	FDA UDI	Class II	Active
Walkaide	0	FDA UDI	Class II	Active
BioGel Velcro Electrode	2	FDA UDI	Class II	Active
LE BioSleeve	0	FDA UDI	Class II	Active
BioGel Velcro Electrode	2	FDA UDI	Class II	Active
BioBelt Lumbar	3	FDA UDI	Class II	Active
Bilateral LE BioSleeves	7	FDA UDI	Class II	Active
BioGel Velcro Electrode	2	FDA UDI	Class II	Active
Wearable Therapy Garments	K141342	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 27, 2011	Z-2899-2011	—	terminated	Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
May 27, 2011	Z-2898-2011	—	terminated	Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
May 27, 2011	Z-2900-2011	—	terminated	Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.
May 27, 2011	Z-2901-2011	—	terminated	Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.