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Sign in to claim this brandSynapse Biomedical, Inc.
United States·US-MF-000029893
Last updated September 18, 2026
About
NOCI envisions a future where effective use of outcome assessments drives the development of novel spinal care treatments. By collaborating with the Spinal Cord Injury (SCI) community, NOCI implements clinical discoveries that lead to impactful solutions and improved patient outcomes. Their services include customized clinical research, outcome measure development, training for healthcare professionals, and independent medical evaluations. As Synapse’s exclusive partner in Canada, NOCI is dedicated to promoting advanced respiratory care and delivering innovative solutions that enhance patient outcomes.
From the manufacturer's own website. Source
What Synapse Biomedical, Inc. makes
Synapse Biomedical, Inc. makes intramuscular diaphragm/phrenic nerve electrical stimulation systems, including external pulse generators, percutaneous stimulation leads, programmers, and active and return electrodes for these systems. Example devices include the NeuRx DPS™ External Pulse Generator, NeuRx DPS™ System Kit, Active Sensor Module, and related accessories such as sterile lead tunnelers, disposable electrode delivery tools, extended-life batteries, silicone adhesive kits, surface electrodes, and connector holder kits.
The company's devices are classified as Class II and Class III and are listed in the FDA 510(k), FDA PMA, and FDA UDI registries. Synapse Biomedical, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Synapse Biomedical, Inc. make?
Synapse Biomedical, Inc. makes intramuscular diaphragm/phrenic nerve electrical stimulation systems, including external pulse generators, percutaneous stimulation leads, programmers, and active and return electrodes for these systems. Example devices include the NeuRx DPS™ External Pulse Generator, NeuRx DPS™ System Kit, Active Sensor Module, and related accessories such as sterile lead tunnelers, disposable electrode delivery tools, extended-life batteries, silicone adhesive kits, surface electrodes, and connector holder kits.
Where is Synapse Biomedical, Inc. based?
Synapse Biomedical, Inc. is based in the United States, as stated in the provided data under the COUNTRY field and confirmed in the SUMMARY section.
Which registries list Synapse Biomedical, Inc.'s devices?
Synapse Biomedical, Inc.'s devices are listed in the FDA 510(k), FDA PMA, and FDA UDI registries, as indicated in the LISTED IN field and reiterated in the SUMMARY section of the provided data.
How are Synapse Biomedical, Inc.'s devices classified?
Synapse Biomedical, Inc.'s devices are classified as Class II and Class III, as specified in the DEVICE CLASSES field and confirmed in the SUMMARY section of the provided data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 300, Artino Street, Oberlin, OH, United States
- Website
- synapsebiomedical.com
- —
- —
- [email protected]
- Phone
- +1 440 774 2488 x137
- PRRC Contact
- Gaurav Pawar
- EUDAMED SRN
- US-MF-000029893
- FDA FEI Number
- —
- DUNS Number
- 138432070
Catalogue (56)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| STERILE Touchproof Cable, White | 21-0026-99 | FDA UDI | Class III | Active |
| STERILE Blue Cable Set | 21-0009-99 | FDA UDI | Class III | Active |
| System Destination Kit, 2-EPG, Canada | 20-0065 | FDA UDI | Class III | Active |
| 2 Pack, Electrode Delivery Tool Kit | 20-0074 | FDA UDI | Class III | Active |
| Synchrony (20-3000) | K242704 | FDA 510(k) | Class II | Active |
| NeuRX Diaphragm Pacing System (DPS) | P200018 | FDA PMA | Class III | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
There are 2 recall records for Synapse Biomedical, Inc., initiated on 2022-05-31 and 2022-07-11, with a status of terminated. The reasons given for the recalls include a defect on the EPG controller printed circuit board assembly that may cause device performance to degrade over time, and a revision to labeling and instructions for use to clarify storage conditions and temperature range symbols. The recall records provide specific details about the defects and revisions made.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 11, 2022 | Z-1561-2022 | — | terminated | Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or the device may stop unexpectedly. |
| May 31, 2022 | Z-1393-2022 | — | terminated | Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material). |