Selectivemed Components, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Guardian Dysphagia Dual Channel Nmes Unit Ref K120922
Regimes: 510(k) Registry: 510(k)Medion 6000 Ref K020476
Regimes: 510(k) Registry: 510(k)Guardian 150 Electrode Ref K083756
Regimes: 510(k) Registry: 510(k)Io-Drive Ref K993081
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Endura Reusable Tens And Nmes Electrodes Ref K946230
Regimes: 510(k) Registry: 510(k)
FDA recalls
2005
- 15 Mar 2005 Z-0799-05 Unclassified (pre-2012) Terminated The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
Full distribution text
- 15 Mar 2005 Z-0799-05 Unclassified (pre-2012) Terminated The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.
Frequently asked questions
How many devices does Selectivemed Components, Inc. have in the registry?
The registry currently lists 7 devices for Selectivemed Components, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Selectivemed Components, Inc.'s devices?
Among its 7 most recently registered devices, Selectivemed Components, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Selectivemed Components, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Selectivemed Components, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Selectivemed Components, Inc.?
FDA recall records list 1 recall initiated by Selectivemed Components, Inc., the most recent initiated on 15 Mar 2005. 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 Selectivemed Components, Inc. in the registry?
The most recently registered devices listed for Selectivemed Components, Inc. include GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT, MEDION 6000, GUARDIAN 150 ELECTRODE and IO-DRIVE.