Labeltape Meditect, Inc.
United StatesFDA applicant, unverified
- Devices
- 26
What Labeltape Meditect, Inc. makes
Labeltape Meditect, Inc. manufactures disposable electrodes for medical diagnostics and therapy, including pre-gelled ECG electrodes for infants and adults, foam-bordered diagnostic electrodes, TENS electrodes for nerve and muscle stimulation, and dispersive electrodes for electrosurgery. Their portfolio also includes repositionable TENS electrodes, neonatal cloth and breathable fabric ECG electrodes, and specialized pads for lumbar and sacral stimulation. Products are designed for single-use applications in clinical and home settings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to FDA oversight for safety and performance. No other regulatory registries or jurisdictions are specified.
Catalogue
Search and filter all 26 devicesFrequently asked questions
How many devices does Labeltape Meditect, Inc. have in the registry?
The registry currently lists 26 devices for Labeltape Meditect, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Labeltape Meditect, Inc.'s devices?
Among its 26 most recently registered devices, Labeltape Meditect, Inc. has devices listed in FDA 510(k) (26 devices).
What risk classes do Labeltape Meditect, Inc.'s devices fall under?
Among its 26 most recently registered devices, the classes recorded for Labeltape Meditect, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Labeltape Meditect, Inc. in the registry?
The most recently registered devices listed for Labeltape Meditect, Inc. include PREGELLED INFANT DISPOSABLE ECG ELECTRODE, FOAM BORDERED DIAGNOSTIC (CARE) ELECTRODE, TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING and LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD.