Mini-Mitter Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Mini-Mitter Co., Inc. makes
Mini-Mitter Co., Inc. manufactures wearable and portable monitoring devices including the ACTIWATCH, MINI-LOGGER SERIES 2000, VITALSENSE, ACTIWATCH‑SCORE, and ACTIWARE‑PLMS, which are used for activity tracking, physiological data logging, and sleep‑related measurements.
All of these devices are classified as Class II medical devices and are listed in the FDA 510(k) database. The company is based in the United States.
Catalogue
Actiwatch Ref K983533
Regimes: 510(k) Registry: 510(k)Mini-Logger Series 2000 Ref K991045
Regimes: 510(k) Registry: 510(k)Vitalsense Ref K033534
Regimes: 510(k) Registry: 510(k)Actiwatch-Score Ref K991033
Regimes: 510(k) Registry: 510(k)Actiware-Plms Ref K011430
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Mini-Mitter Co., Inc., initiated on 2007-06-27. By recorded status: 4 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.
2007
- 27 Jun 2007 Z-0324-2008 Unclassified (pre-2012) Terminated Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.
- 27 Jun 2007 Z-0325-2008 Unclassified (pre-2012) Terminated Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.
- 27 Jun 2007 Z-0326-2008 Unclassified (pre-2012) Terminated Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.
- 27 Jun 2007 Z-0327-2008 Unclassified (pre-2012) Terminated Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.
Frequently asked questions
How many devices does Mini-Mitter Co., Inc. have in the registry?
The registry currently lists 5 devices for Mini-Mitter Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mini-Mitter Co., Inc.'s devices?
Among its 5 most recently registered devices, Mini-Mitter Co., Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Mini-Mitter Co., Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Mini-Mitter Co., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mini-Mitter Co., Inc.?
FDA recall records list 4 recalls initiated by Mini-Mitter Co., Inc., the most recent initiated on 27 Jun 2007. 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 Mini-Mitter Co., Inc. in the registry?
The most recently registered devices listed for Mini-Mitter Co., Inc. include ACTIWATCH, MINI-LOGGER SERIES 2000, VITALSENSE and ACTIWATCH-SCORE.