510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Axiobionics, LLC, Center for Neuroprosthetics

Ann Arbor, MI, US

Axiobionics, LLC, Center for Neuroprosthetics appears in FDA device records in Ann Arbor, MI. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
4
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Axiobionics, LLC, Center for Neuroprosthetics carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Axiobionics, LLC510(k), recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Axiobionics, LLC, Center for Neuroprosthetics in 2014.

Clearances by year, as a table
510(k) clearance decisions for Axiobionics, LLC, Center for Neuroprosthetics, by decision year
YearClearances
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K141342WEARABLE THERAPY GARMENTSGXYSubstantially Equivalent

Registered establishments

FDA registered establishments for Axiobionics, LLC, Center for Neuroprosthetics, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30085254543008525454Axiobionics, LLC, Center for Neuroprosthetics6111 Jackson Road, Ann Arbor, MI 48103 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2901-2011AxioBionics Wearable Therapy BioVest/Unitard that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation.Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.Terminated
Z-2900-2011AxioBionics Wearable Therapy BioShorts that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation.Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.Terminated
Z-2899-2011AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation.Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.Terminated
Z-2898-2011AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". Cutaneous electrode garments for neuromuscular electrical stimulation.Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain