Non-Invasive Monitoring Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Non-Invasive Monitoring Systems, Inc. makes
Non-Invasive Monitoring Systems, Inc. manufactures respiratory monitoring devices, including wearable sensors like Respibands and Respitrace Plus for continuous non-invasive ventilation tracking, as well as the Respitrace PT for patient-specific calibration. The company also produces Respitrak for real-time respiratory rate measurement and Respicentral for central respiratory monitoring. Additionally, it offers RespEvents software, a PC-based tool for processing and analyzing respiratory event data from connected devices.
The company’s portfolio is classified under FDA’s Class II regulatory category and includes devices authorised via the 510(k) clearance pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Respitrace Plus, Respibands, And Respicentral Ref K903011
Regimes: 510(k) Registry: 510(k)Respitrace Pt Ref K942852
Regimes: 510(k) Registry: 510(k)Respitrak Ref K884959
Regimes: 510(k) Registry: 510(k)Respievents, Version 4.2 Ref K001369
Regimes: 510(k) Registry: 510(k)Respievents Ref K942771
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Non-Invasive Monitoring Systems, Inc., initiated on 2012-05-07. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 7 May 2012 Z-1819-2012 Class II Terminated Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
- 7 May 2012 Z-1820-2012 Class II Terminated Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Frequently asked questions
How many devices does Non-Invasive Monitoring Systems, Inc. have in the registry?
The registry currently lists 6 devices for Non-Invasive Monitoring Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Non-Invasive Monitoring Systems, Inc.'s devices?
Among its 6 most recently registered devices, Non-Invasive Monitoring Systems, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Non-Invasive Monitoring Systems, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Non-Invasive Monitoring Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Non-Invasive Monitoring Systems, Inc.?
FDA recall records list 2 recalls initiated by Non-Invasive Monitoring Systems, Inc., the most recent initiated on 7 May 2012. 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 Non-Invasive Monitoring Systems, Inc. in the registry?
The most recently registered devices listed for Non-Invasive Monitoring Systems, Inc. include RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL, RESPITRACE PT, RESPITRAK and RESPIEVENTS, VERSION 4.2.