SYNAPSE BIOMEDICAL INC.

FDA Device Registration & Listing · Oberlin, OH, US · Registration 3005868392

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005868392
FEI Number
3005868392
Entity Name
SYNAPSE BIOMEDICAL INC.
City/State/Country
Oberlin, OH, US
Establishment Address
300 Artino Street, Oberlin, OH 44074, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Synapse Biomedical Inc. (Owner Number: 10024968)
Owner / Operator Contact Address
300 Artino Street, Oberlin, OH 44074, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242704
PMA Number
N/A

All Registered Proprietary Names

NeuRx DPS NeuRx Diaphragm Pacing System NeuRx Diaphragm Pacing System Synchrony

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OIR Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator Unknown Class 3 N/A 2012-11-28
OIR Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator Unknown Class 3 N/A 2023-12-06
KQX Goniometer, Ac-Powered Orthopedic Class 1 888.1500 2025-08-20
IPF Stimulator, Muscle, Powered Physical Medicine Class 2 890.5850 2025-08-20
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2025-08-20

Official Correspondent

Gaurav Pawar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Synapse Biomedical Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K030403 Cefar Medical AB CEFAR REHAB 2 AND REHAB 2 PRO 2003-07-17
K231440 Shenzhen Roundwhale Technology Co. , Ltd. Combo Electrotherapy Device 2023-11-03
K820884 Nitron Electronics ELECTRICAL MUSCLE STIMULATOR 1982-04-29
K201958 Therasigma, LLC ETD Family of Electrotherapy Devices 2020-08-04
K964028 Mettler Electronics Corp. SYS STIM 226 1997-02-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005868392. Last updated year: 2026. Please use registration number 3005868392 when referencing this establishment in official correspondence.
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