Data / Medical devices / Mexico / Tutamen De Mexico, LLC

Tutamen De Mexico, LLC: FDA-registered device maker in Tijuana Baja California, Mexico, 5 510(k) clearances

Name: Tutamen De Mexico, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tutamen De Mexico, LLC is registered with the FDA (registration 3013591868) in Tijuana Baja California, Mexico. It lists 19 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 13, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3013591868
Address: Calle 9 sur ext 101 ciudad industrial Baja Maq el Aguila, Tijuana Baja California, Mexico, 22444
Owner or operator: Tutamen de Mexico, LLC (10055035)
Roles: Manufacturer
First device listed: July 7, 2017
Registered through: 2027
Brand names listed: Apex Ill Organizers, Apex Liquid Medicine Dispenser, OG Back Brace, OGYILI TENS/NMES Stimulator, PBM Therapy, Procare Flat Collar, REVIAN LYTE, REVIAN RED and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Traction	ILZ	1	Manufacturer	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Crutch	IPR	1	Manufacturer	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Manufacturer	accessdata.fda.gov
Dispenser, Solid Medication	NXB	1	Manufacturer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Manufacturer	accessdata.fda.gov
Immunoglobulin G (Igg) Infusion System	PKP	2	Manufacturer	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Manufacturer	accessdata.fda.gov
Joint, Hip, External Brace	ITS	1	Manufacturer	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Manufacturer	accessdata.fda.gov
Orthosis, Cervical	IQK	1	Manufacturer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Manufacturer	accessdata.fda.gov
Orthosis, Lumbar	IQE	1	Manufacturer	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Manufacturer	accessdata.fda.gov
Sling, Arm	ILI	1	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Unit, Heating, Powered	IRQ	1	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
September 13, 2024	K242441	Revian Lyte (10011)	OAP	Substantially Equivalent	Revian, Inc.	accessdata.fda.gov
February 16, 2024	K240148	SCIg60 Infusion System	PKP	Substantially Equivalent	Emed Technologies Corporation	accessdata.fda.gov
November 9, 2020	K201431	OGYILI TENS/NMES Stimulator	GZJ	Substantially Equivalent	Gongguan Tutamen Metalwork Co., Ltd.	accessdata.fda.gov
February 28, 2018	K173729	REVIAN RED	OAP	Substantially Equivalent	Photonmd, Inc.	accessdata.fda.gov
April 1, 2016	K160318	PlasmaFlow	JOW	Substantially Equivalent	Manamed, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 13, 2024. 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.