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Synapse 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?

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
LinkedIn: —
Facebook: —
Email: [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 1 of 2

Device	Model / Reference	Registries	Class	Status
NeuRx DPS™ External Pulse Generator	23-0021	FDA UDI	Class III	Active
Active Sensor Module	23-0007	FDA UDI	Class III	Active
NeuRx DPS™ System Kit	20-0030	FDA UDI	Class III	Active
Clinical Station Kit, ALS HDE	20-0071	FDA UDI	Class III	Active
STERILE Lead Tunnelers	21-0007-99	FDA UDI	Class III	Active
Disposable Electrode Delivery Tool	21-0039-99	FDA UDI	Class III	Active
Extended-Life Battery - 3 Pack	22-0020	FDA UDI	Class III	Active
Silicone Adhesive Kit	22-0009	FDA UDI	Class III	Active
Surface Electrode, Single-Pack	22-0031	FDA UDI	Class III	Active
External Pulse Generator	23-0001	FDA UDI	Class III	Active
NeuRx Diaphragm Pacing System	20-0035	FDA UDI	Class III	Active
Connector Holder Kit	22-0004	FDA UDI	Class III	Active
Patient Cable	22-0011	FDA UDI	Class III	Active
NeuRx DPS Patient Kit	20-0036	FDA UDI	Class III	Active
STERILE Indifferent Electrode	21-0004-99	FDA UDI	Class III	Active
Surgical Site Start-up Kit, ALS HDE	20-0070	FDA UDI	Class III	Active
NeuRx DPS™ Surgical Kit, HDE	20-0028	FDA UDI	Class III	Active
NeuRx DPS™ Pacing System, European CE Patient Kit	20-0025	FDA UDI	Class III	Active
Spare Surgical Kit	20-0040	FDA UDI	Class III	Active
STERILE Trocar to Transducer Tubing	21-0010-99	FDA UDI	Class III	Active
System Kit, ALS HDE	20-0045	FDA UDI	Class III	Active
NeuRx DPS™ System Kit, Canada	20-0032	FDA UDI	Class III	Active
NeuRx DPS™ Surgical Site Start-up Kit, SCI HDE	20-0007	FDA UDI	Class III	Active
NeuRx DPS™ Patient Kit, 1 EPG	20-0046	FDA UDI	Class III	Active
STERILE Touchproof Cable, Green	21-0023-99	FDA UDI	Class III	Active
Anode Replacement Parts Kit	20-0043	FDA UDI	Class III	Active
STERILE Touchproof Cable Yellow	21-0025-99	FDA UDI	Class III	Active
NeuRx DPS™ Surgical Kit	20-0018	FDA UDI	Class III	Active
STERILE PermaLoc Electrode, 60cm	21-0017-99	FDA UDI	Class III	Active
Electrode Delivery Tool Kit, MedCoat, HDE	22-0034	FDA UDI	Class III	Active
NeuRx DPS™ System Kit, ALS CE	20-0031	FDA UDI	Class III	Active
System Destination Kit, ALS HDE, US	20-0062	FDA UDI	Class III	Active
Surgical Connector Kit	22-0028	FDA UDI	Class III	Active
Airline Travel Battery Pack	22-0021	FDA UDI	Class III	Active
Clinical Station Kit	20-0038	FDA UDI	Class III	Active
NeuRx DPS™ Clinical Station Kit, HDE	20-0037	FDA UDI	Class III	Active
System Destination Kit, SCI HDE, US	20-0061	FDA UDI	Class III	Active
STERILE Mapping Probe	21-0001-99	FDA UDI	Class III	Active
Clinical Station	23-0008	FDA UDI	Class III	Active
NeuRx DPS™ Pacing System, European CE Patient Kit	20-0024	FDA UDI	Class III	Active
STERILE Touchproof Cable, Orange	21-0024-99	FDA UDI	Class III	Active
NeuRx DPS™ Surgical Site Start-up Kit	20-0039	FDA UDI	Class III	Active
System Destination Kit, ALS CE	20-0064	FDA UDI	Class III	Active
Clinician Crimp Tool	22-0022	FDA UDI	Class III	Active
Surface Electrode, 4-pack with Interconnect	22-0034	FDA UDI	Class III	Active
Electrode Delivery Tool Kit MedCoat, CE	22-0018	FDA UDI	Class III	Active
System Destination Kit, CE 2 EPG	20-0063	FDA UDI	Class III	Active
Socket Pusher	23-0010	FDA UDI	Class III	Active
Clinician Connector Repair Parts Kit	22-0030	FDA UDI	Class III	Active
Clinician Connector Kit	22-0029	FDA UDI	N/A	Active

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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).