Device, Nerve Conduction Velocity Measurement
Neurology · 21 CFR 882.1550
Recent MDR events
93 adverse event reports on file
- ULTRA-DRIVE III CONSOLEMar 31, 2026InjuryZimmer Biomet, Inc.MW5186133
- NERVE CONDUCTION TEST MACHINEDec 30, 2025InjuryUnkMW5181478
- SPINAL ELECTRODEOct 25, 2024MalfunctionAd-tech Medical Instrument Corp.2183456-2024-00010
- ULTRA-DRIVE III CONSOLEOct 1, 2019InjuryZimmer Biomet, Inc.0001825034-2019-04313
- ULTRA DRIVE 180MM TIP EXTENDERNov 26, 2018InjuryZimmer Biomet, Inc.0001825034-2018-10538
- ULTRA-DRIVE III HANDPIECEAug 29, 2018MalfunctionZimmer Biomet, Inc.0001825034-2018-08619
- ULTRA-DRIVE III HANDPIECEAug 29, 2018MalfunctionZimmer Biomet, Inc.0001825034-2018-08618
- ULTRA-DRIVE III CONSOLEAug 24, 2018InjuryZimmer Biomet, Inc.0001825034-2018-08518
- ULTRA-DRIVE III HANDPIECEAug 24, 2018InjuryZimmer Biomet, Inc.0001825034-2018-08520
- ULTRA-DRIVE III HANDPIECEAug 24, 2018InjuryZimmer Biomet, Inc.0001825034-2018-08521
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
48 firms currently registered for this product code
Rhythmlink International, Llc
Columbia, SC, US
Fideltronik Poland Sp. Z O.o.
Sucha Beskidzka Malopolskie, PL
Cirtec Medical
Brooklyn Park, MN, US
Cadwell Industries, Inc.
KENNEWICK, WA, US
Natus Neurology Incorporated
Middleton, WI, US
Pine Moon Electronics Co., Ltd.
SHENZHEN CITY Guangdong, CN
Ad-tech Medical Instrument Corp.
Oak Creek, WI, US
Natus Manufacturing Limited
GORT, Co. Galway, IE
Mediracer Ltd.
Oulu Kainuu, FI
Paul E. Danchell A/s
Jyderup Sjalland, DK
Nihon Kohden Corp.
SHINJUKU-KU Tokyo, JP
Medical Measurement Systems B.v.
HENGELO Overijssel, NL
Teleemg, Llc
E Falmouth, MA, US
Nihon Kohden Corporation - Eastern Japan Logistics Center
Sakado City Saitama, JP
Nihon Kohden Tomioka Corporation
Gunma Tokyo, JP
The Electrode Store
Buckley, WA, US
Nihon Kohden America, Inc.
Irvine, CA, US
Neurosoft Ltd
Ivanovo Ivanovskaya Oblast', RU
510(k) clearances
27 clearances for this product code
- Mde Orvosbiológiai Kutató, Fejleszto,Mar 26, 2025
K240189 · NM-01/CPT neurometer (NM-01/CPT)
- Mediracer OYSep 25, 2019
K190536 · Mediracer NCS
- Neurometrix, Inc.Apr 25, 2008
K070109 · NEUROMETRIX ADVANCE
- Neurometrix, Inc.Jul 31, 2006
K060584 · NC-STAT
- Excel Tech. , Ltd.Feb 7, 2006
K053058 · XLTEK NEUROPATH, MODEL PK1070
- Scientific Imaging, Inc.Oct 27, 2005
K052904 · VIRTUAL MEDICAL SYSTEMS MODEL VT3000
- Neurometrix, Inc.Aug 12, 2004
K041320 · MODIFICATION TO NC-STAT
- Neurometrix, Inc.Jan 17, 2002
K013459 · MODIFICATION OF NC-STAT