Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032273

FEI Number

3003240904

Entity Name

TRUER MEDICAL, INC.

City/State/Country

ORANGE, CA, US

Establishment Address

1050 N Batavia St Ste C, ORANGE, CA 92867, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TRUER MEDICAL, INC. (Owner Number: 9043471)

Owner / Operator Contact Address

1050 NORTH BATAVIA, UNIT C, --, Orange, CA 92867, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101244

PMA Number

N/A

All Registered Proprietary Names

Voir Bougie Tactical Bougie Truer Bougie Gas Sampling Line Truer Medical, Inc. Head Strap Migratherapy LLC TMJ QuickSplint Quick Spint Intubation Stylet RPiS RAPID POSITIONING INTUBATION STYLET General Purpose Probes, Tympanic Probes, Skin Sensing Probes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCD	Bougie, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2010-06-08
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2000-10-26
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2015-09-11
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2013-05-28
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2000-11-13
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2010-12-06

Official Correspondent

Tim Truitt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TRUER MEDICAL, 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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

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3014129616	ADROIT SURGICAL LLC	Oklahoma City, OK, US
8030607	Industrias Apson S.A de C.V	AGUA PRIETA Sonora, MX
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032273. Last updated year: 2026. Please use registration number 2032273 when referencing this establishment in official correspondence.