Data / Medical devices / United States / Tenovi Co

Tenovi Co: FDA-registered device maker in Portsmouth, NH, United States, 12 510(k) clearances

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

Tenovi Co is registered with the FDA (registration 3017520431) in Portsmouth, NH, United States. It lists 13 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 27, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017520431
Address: 1 Cate Street STE 100, Portsmouth, NH, United States, 03801
Owner or operator: Tenovi Co (10078484)
Roles: Complaint file establishment, Repackager or relabeler, Specification developer
First device listed: October 23, 2020
Registered through: 2026
Brand names listed: Tenovi Bluetooth Pillbox Generation 1

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Body Composition, Exempt	PUH	2	Repackager or relabeler	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Repackager or relabeler	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Repackager or relabeler	accessdata.fda.gov
Dispenser, Solid Medication	NXB	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Meter, Peak Flow, Spirometry	BZH	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Ultrasonic, Fetal	KNG	2	Repackager or relabeler	accessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
Scale, Stand-On, Patient	FRI	1	Repackager or relabeler	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Repackager or relabeler	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
October 27, 2025	K251331	Blood Pressure Monitor (B73, BE23T)	DXN	Substantially Equivalent	Shenzhen Jamr Technology Co., Ltd.	accessdata.fda.gov
August 21, 2024	K241351	Blood Pressure Monitor (TMB-2092-G)	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
June 28, 2023	K223722	MIO Blood Glucose Monitoring System	NBW	Substantially Equivalent	Mio Labs, Inc.	accessdata.fda.gov
July 6, 2022	K220475	Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)	QRL	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.	accessdata.fda.gov
May 26, 2021	K203196	Peak flow meter	BZH	Substantially Equivalent	Shanghai Sonmol Medical Equipment Co., Ltd.	accessdata.fda.gov
March 9, 2021	K202891	Blood Pressure Monitor	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov
March 14, 2018	K172795	Infrared Thermometer	FLL	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
December 13, 2017	K171480	NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System	NBW	Substantially Equivalent	I-Sens, Inc.	accessdata.fda.gov
November 3, 2017	K170965	Fingertip Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
August 28, 2014	K140582	FINGERTIP PULSE OXIMETER	DQA	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
January 24, 2014	K131457	FETAL ULTRASONIC MONITOR AND ACCESSORIES	KNG	Substantially Equivalent	Shenzhen Jumper Medical Equipment Co., Ltd.	accessdata.fda.gov
June 19, 2013	K131395	TRANSTEK BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	Guangdong Transtek Medical Electronics Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 27, 2025. 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.