MYOLYN, INC

FDA Device Registration & Listing · Gainesville, FL, US · Registration 3013503259

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
3013503259
FEI Number
3013503259
Entity Name
MYOLYN, INC
City/State/Country
Gainesville, FL, US
Establishment Address
6931 NW 22ND ST # A, Gainesville, FL 32653, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
MYOLYN, INC (Owner Number: 10054807)
Owner / Operator Contact Address
6931 NW 22ND ST # A, Gainesville, FL 32653, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K213925
PMA Number
N/A

All Registered Proprietary Names

MyoCycle MC-2 (Home / Home + / Pro / Pro +)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GZI Stimulator, Neuromuscular, External Functional Neurology Class 2 882.5810 2022-11-28

Official Correspondent

Matthew Bellman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MYOLYN, INC
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013503259. Last updated year: 2026. Please use registration number 3013503259 when referencing this establishment in official correspondence.
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