Neuro Resource Group, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Neuro Resource Group, Inc. makes
Neuro Resource Group, Inc. manufactures transcutaneous electrical nerve stimulation (TENS) devices and flexible array electrodes for medical and cosmetic applications. Their products include stimulators like the INTERX 1000 and DERMA 200, designed for non-invasive pain relief and cosmetic treatments, as well as reusable and sterile electrode systems such as the INTERX500 and INTERX5000.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company’s portfolio is listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
INTERX500 Flexible Array Electrode Ref K053626
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
INTERX5000 Ref K042912
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Neuro Resource Group, Inc., initiated on 2011-02-07. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 7 Feb 2011 Z-2105-2011 Unclassified (pre-2012) Terminated Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism.
Frequently asked questions
How many devices does Neuro Resource Group, Inc. have in the registry?
The registry currently lists 4 devices for Neuro Resource Group, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neuro Resource Group, Inc.'s devices?
Among its 4 most recently registered devices, Neuro Resource Group, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Neuro Resource Group, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Neuro Resource Group, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Neuro Resource Group, Inc.?
FDA recall records list 1 recall initiated by Neuro Resource Group, Inc., the most recent initiated on 7 Feb 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Neuro Resource Group, Inc. in the registry?
The most recently registered devices listed for Neuro Resource Group, Inc. include INTERX500 FLEXIBLE ARRAY ELECTRODE, INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE, INTERX5000 and INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE).