Alternative Design Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Alternative Design Systems, Inc. makes
Alternative Design Systems, Inc. manufactures medical devices for respiratory monitoring, electrotherapy, and electrocardiographic (ECG) applications. Their products include ventilatory frequency monitors, electrosurgical units (ESU), transcutaneous electrical nerve stimulation (TENS) conductive media pads, ECG electrodes, and monitoring kits designed for clinical use.
The company’s portfolio consists of Class II devices, all of which are subject to FDA 510(k) clearance requirements. These devices are listed under the FDA’s regulatory framework and are intended for use in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Stratum Esu Ref K874719
Regimes: 510(k) Registry: 510(k)Tens Conductive Media Pad Ref K853633
Regimes: 510(k) Registry: 510(k)5000 Series Ecg Electrodes Ref K854757
Regimes: 510(k) Registry: 510(k)Stratum D Ref K874697
Regimes: 510(k) Registry: 510(k)Monitoring Kit Amk-1 Ref K830778
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alternative Design Systems, Inc. have in the registry?
The registry currently lists 6 devices for Alternative Design Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alternative Design Systems, Inc.'s devices?
Among its 6 most recently registered devices, Alternative Design Systems, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Alternative Design Systems, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Alternative Design Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alternative Design Systems, Inc. in the registry?
The most recently registered devices listed for Alternative Design Systems, Inc. include ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR, STRATUM ESU, TENS CONDUCTIVE MEDIA PAD and 5000 SERIES ECG ELECTRODES.