Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013896610

FEI Number

3013896610

Entity Name

Hypertec HCM LLC

City/State/Country

Plainfield, IN, US

Establishment Address

1570 Perry Road, Plainfield, IN 46168, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Hypertec HCM LLC (Owner Number: 10053193)

Owner / Operator Contact Address

1570 Perry Rd, Plainfield, IN 46168, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No Proprietary Name No Proprietary Name No Proprietary Name No Proprietary Name No Proprietary Name No Proprietary Name No Proprietary Name No Proprietary Name No Proprietary Name No Proprietary Name No Proprietary Name

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2021-02-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2021-02-16
LEL	Device, Sleep Assessment	Neurology	Class 2	882.5050	2024-02-07
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-02-07
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-02-07
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2024-02-07
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-02-07
GZO	Device, Galvanic Skin Response Measurement	Neurology	Class 2	882.1540	2024-02-07
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-02-07
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-02-06
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2024-02-06
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-02-06
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-02-06
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2024-02-06
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-02-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2021-02-16
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2021-02-16
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2021-02-16
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2016-11-16
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2021-02-16
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2021-02-16

Official Correspondent

John Pichon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hypertec HCM LLC

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0043-06	Abbott Laboratories Medisense Products	2	Tracker Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0044-06	Abbott Laboratories Medisense Products	2	Xceed Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651

Similar Registrations

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1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013896610. Last updated year: 2026. Please use registration number 3013896610 when referencing this establishment in official correspondence.