Stimulator, Neuromuscular, External Functional
Neurology · 21 CFR 882.5810
Recent MDR events
50 adverse event reports on file
- CHATTANOOGAApr 30, 2025InjuryDjo Llc9616086-2025-00048
- CHATANOOGA GROUP E-STIM VECTRA GENISYSApr 7, 2025MalfunctionDjo, LlcMW5168659
- NEURAL SLEEVEJan 2, 2025InjuryCionic FacilityMW5164260
- CIONIC NEURAL SLEEVE NS-100Jun 24, 2024InjuryCionic Inc3019892999-2024-00001
- MYOCYCLE MC-2Jan 19, 2023InjuryMyolyn, Inc.3013503259-2023-00001
- VECTRA GENISYSDec 21, 2022InjuryDjo Llc9616086-2022-00032
- MYOCYCLE MC-2Nov 17, 2022InjuryMyolyn, Inc.3013503259-2022-00002
- MYOCYCLE MC-2Aug 11, 2022MalfunctionMyolyn Inc.3013503259-2022-00001
- VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPLOct 13, 2021InjuryDjo Llc9616086-2021-00016
- CHATTANOOGA VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPLDec 23, 2019MalfunctionDjo, Llc9616086-2019-00085
Event type breakdown
Recalls
2 recall events for this product code
- Innovative Neurotronics, Inc.TerminatedJun 3, 2009
WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX
Knob responsible for regulating the amount of stimulation administered by the WalkAide System control unit may fall off while device is in use.
Z-1435-2009 · View FDA record ↗ - Myolyn Inc.TerminatedUnknown
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
Z-1523-2022 · View FDA record ↗
Registered firms
74 firms currently registered for this product code
Djo, Llc
Carlsbad, CA, US
Restorative Therapies Inc.
Nottingham, MD, US
Bioness Medical, Inc.
Valencia, CA, US
Verity Medical Ltd (ireland)
Tagoat Wexford, IE
Ibramed Industria Brasileira De Equipamentos Medicos Ltda
Amparo Sao Paulo, BR
Drive Northpoint, Llc
Palmetto, GA, US
Dj Orthopedics De Mexico, S.a. De C.v.
TIJUANA Baja California, MX
Cionic Facility
Scotts Valley, CA, US
Amrex-zetron, Inc.
Paramount, CA, US
Innovative Neurotronics Inc.
Reno, NV, US
Xemis Medical Technology (shenzhen) Co., Ltd.
Shenzhen Guangdong, CN
G.tec Medical Engineering Gmbh
Graz Steiermark, AT
Myndtec Inc
Mississauga Ontario, CA
Odstock Medical Ltd
SALISBURY Wiltshire, GB
Bioventus Llc
Cordova, TN, US
Guangzhou Longest Medical Technology Co., Ltd.
Guangzhou Guangdong, CN
Medline Industries, Lp - Northfield
Northfield, IL, US
510(k) clearances
61 clearances for this product code
- Synapse Biomedical, Inc.Jun 5, 2025
K242704 · Synchrony (20-3000)
- Cionic, Inc.May 2, 2025
K243828 · CIONIC NEURAL SLEEVE (NS-200)
- Neuvotion, Inc.Nov 22, 2024
K240632 · Neuvotion NeuStim NN-01
- Myndtec, Inc.Jun 25, 2024
K233006 · MyndMove, MyndMove 2.0
- Evolution Devices, Inc.Dec 28, 2023
K230997 · EvoWalk 1.0 System
- CionicJul 21, 2022
K221823 · Cionic Neural Sleeve NS-100
- Myolyn, LLCApr 25, 2022
K213925 · MyoCycle MC-2 (Home / Home + / Pro / Pro +)
- Myndtec, Inc.Mar 3, 2022
K212149 · MyndMove 2.0