Ondamed Inc.
United Statesfrom the FDA registration address FDA FEI 3011088301
Ondamed Inc. is a medical device manufacturer, with 16 devices listed in FDA GUDID (FDA Class II) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 16
- Registrations
- FDA
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 16
- Device classes
- FDA Class II 16
- FDA recalls
- Identifiers
- FDA FEI 3011088301
- DUNS 841720167
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Ondamed Inc. makes
Ondamed Inc. manufactures biofeedback systems designed to provide real-time physiological feedback for therapeutic and diagnostic purposes. These devices are primarily used in clinical and research settings to monitor and train patients in self-regulation of bodily functions, such as muscle activity, heart rate variability, and respiratory patterns.
The company’s portfolio is regulated under Class II medical devices in the United States and is listed in the FDA’s Unique Device Identifier (UDI) database.
Catalogue
Search and filter all 16 devicesCompany details
- FDA FEI number
- 3011088301
- DUNS number
- 841720167
- Address
- 5 FAIRLAWN DR STE 200, WASHINGTONVILLE, NY, 10992
- support@ondamed.net
- Phone
- 8455340456
FDA recalls
FDA recall records list 1 recall initiated by ONDAMED INC., initiated on 2017-07-07. By recorded status: 1 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.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 7 Jul 2017 Z-1782-2018 Class II Terminated The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers that an upgrade for the device is now available, which includes the addition of direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content SpO2.
Frequently asked questions
How many devices does ONDAMED INC. have in the registry?
The registry currently lists 16 devices for ONDAMED INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ONDAMED INC.'s devices?
Among its 16 most recently registered devices, ONDAMED INC. has devices listed in FDA GUDID (16 devices).
What risk classes do ONDAMED INC.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for ONDAMED INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ONDAMED INC.?
FDA recall records list 1 recall initiated by ONDAMED INC., the most recent initiated on 7 Jul 2017. 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 ONDAMED INC. in the registry?
The most recently registered devices listed for ONDAMED INC. include ONDAMED 001-05-0101, ONDAMED 001-50-0101, ONDAMED 001-55-0101 and ONDAMED 001-52-0101.