Data / Medical devices / United States / Precision Medical Products

Precision Medical Products: FDA-registered device maker in Rocklin, CA, United States, 5 510(k) clearances

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

Precision Medical Products is registered with the FDA (registration 3016000973) in Rocklin, CA, United States. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 3, 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: 3016000973
Address: 3735 Cincinnati Ave Ste 100, Rocklin, CA, United States, 95765
Owner or operator: Precision Medical Products Inc. (10084351)
Roles: Specification developer
First device listed: February 13, 2022
Registered through: 2026
Brand names listed: Circul8 Connect DVT Prevention Device, Circul8 Luxe DVT Prevention Device, Circul8 Max Vascular Therapy System, Circul8 Pro, Circul8One, Cryo Ankle Brace, Cryo ROM Knee, Cryo Shoulder and more

Devices it lists

Device	Product code	Class	Role	Source
Joint, Ankle, External Brace	ITW	1	Specification developer	accessdata.fda.gov
Joint, Hip, External Brace	ITS	1	Specification developer	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Specification developer	accessdata.fda.gov
Orthosis, Limb Brace	IQI	1	Specification developer	accessdata.fda.gov
Orthosis, Lumbo-Sacral	IPY	1	Specification developer	accessdata.fda.gov
Sleeve, Limb, Compressible	JOW	2	Specification developer	accessdata.fda.gov
Sling, Arm	ILI	1	Specification developer	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
June 3, 2022	K220761	CIRCUL8 Connect DVT Prevention Device	JOW	Substantially Equivalent	Ortho8, Inc.	accessdata.fda.gov
November 15, 2021	K212731	Circul8 Pro	JOW	Substantially Equivalent	Ortho8, Inc.	accessdata.fda.gov
September 8, 2021	K211235	CIRCUL8 Luxe DVT Prevention Device	JOW	Substantially Equivalent	Ortho8, Inc.	accessdata.fda.gov
July 2, 2020	K200285	VenaOne	JOW	Substantially Equivalent	Vena Group, LLC	accessdata.fda.gov
December 4, 2019	K193020	VenaPro Vascular Therapy System	JOW	Substantially Equivalent	Innovamed Health, 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 9, 2021	88308	Class II	Ongoing	CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free	CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance	accessdata.fda.gov

Compare with other makers

Updated June 3, 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.