510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Innovative Neurotronics, Inc.

Reno, NV, US

INNOVATIVE NEUROTRONICS INC. appears in FDA device records in Reno, NV. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Innovative Neurotronics, Inc. between 2005 and 2014. The busiest year on record is 2005, with 1. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Innovative Neurotronics, Inc., by decision year
YearClearances
20051
20131
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K140886WALKAIDE SYSTEMGZISubstantially Equivalent
K123972WALKAIDE SYSTEMGZISubstantially Equivalent
K052329WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000GZISubstantially Equivalent

Registered establishments

FDA registered establishments for Innovative Neurotronics, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30056945043005694504INNOVATIVE NEUROTRONICS INC.1170 Trademark Dr Ste 104, Reno, NV 89521 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-1435-2009WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746. The WalkAide is a battery operated, single channel electrical stimulator that is used to improve walking ability by stimulating a foot lift at the appropriate time during the step cycle.Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use.Terminated

Verification record

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