Data / Medical devices / United States / Myolyn, Inc

Myolyn, Inc: FDA-registered device maker in Gainesville, FL, United States, 2 510(k) clearances

Name: Myolyn, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Myolyn, Inc is registered with the FDA (registration 3013503259) in Gainesville, FL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated April 25, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013503259
Address: 6931 NW 22ND ST # A, Gainesville, FL, United States, 32653
Owner or operator: MYOLYN, INC (10054807)
Roles: Manufacturer
First device listed: April 28, 2017
Registered through: 2026
Brand names listed: MyoCycle Home, MyoCycle MC-2 (Home / Home + / Pro / Pro +), MyoCycle Pro

Devices it lists

Device	Product code	Class	Role	Source
Stimulator, Neuromuscular, External Functional	GZI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 25, 2022	K213925	MyoCycle MC-2 (Home / Home + / Pro / Pro +)	GZI	Substantially Equivalent	Myolyn, LLC	accessdata.fda.gov
April 25, 2017	K170132	MyoCycle Home, MyoCycle Pro	GZI	Substantially Equivalent	Myolyn, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 19, 2022	90620	Class II	Terminated	Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.	Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.	accessdata.fda.gov

Compare with other makers

All makers of Stimulator, Neuromuscular, External Functional

Updated April 25, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.