FDA.reportPublic FDA data

NEUROMETRIX, INC.

Matched from indexed company URL: NeuroMetrix, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30114121513011412151NEUROMETRIX, INC.1N2026-01-01200 Forge Way Ste 205 Rockaway NJ US 07866

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00851221006087NC-stat DPNCheck - NC-stat DPNCheck BiosensorDB-025 = QTY 25 OF NC-DP2DB-050 = QTY 50 OF NC-DP2781-314-2781rainer_maas@neurometrix.com
00851221006100ADVANCE - Peroneal Biosensor (Left) Individual781-314-2781rainer_maas@neurometrix.com
00851221006117ADVANCE - Superficial Peroneal Biosensor (Right) Individual781-314-2781rainer_maas@neurometrix.com
00851221006124ADVANCE - Superficial Peroneal Biosensor (Left) Individual781-314-2781rainer_maas@neurometrix.com
00851221006131ADVANCE - Tibial Biosensor (Right) Individual781-314-2781rainer_maas@neurometrix.com
00851221006148ADVANCE - Tibial Biosensor (Left) Individual781-314-2781rainer_maas@neurometrix.com
00851221006162ADVANCE - Ulnar Wrist Biosensor (Left) Individual781-314-2781rainer_maas@neurometrix.com
00851221006193ADVANCE - Sural Biosensor (Right) Individual781-314-2781rainer_maas@neurometrix.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1825931343980434K982359NC-STATJXE1998-10-02
1825931241803367K152954QuellNUH2016-01-05
1825931139320751K140586ASCEND ELECTRODEGXY2014-11-17
1825931921774906K140333ASCENDNUH2014-07-03
1825931739251525K130919SENSUSGZJ2013-07-02
1825931923457299K121184SENSUSGZJ2012-08-02
1825931152623966K070109NEUROMETRIX ADVANCEJXE2008-04-25
1825931012299166K060584NC-STATJXE2006-07-31
1825931643249459K041320MODIFICATION TO NC-STATJXE2004-08-12
1825931360272119K013459MODIFICATION OF NC-STATJXE2002-01-17
1825931723824092K003508NC-STATJXE2001-01-17
1825931654918749K000565MODIFICATION TO NC-STATJXE2000-06-27
1825931104652181DEN210046Quell-FMQSQ2022-05-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXE72008-04-25
NUH22016-01-05
GZJ22013-07-02
QSQ12022-05-18
GXY12014-11-17

PMN#

Quell

2016-01-05

NEUROMETRIX, INC.

ASCEND

2014-07-03

NEUROMETRIX, INC.

SENSUS

2013-07-02

NEUROMETRIX, INC.

SENSUS

2012-08-02

NEUROMETRIX, INC.

ASCEND

2009-09-03

NEUROMETRIX, INC.

GUDID#

78 records. Showing 1-40. Next