Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016000973

FEI Number

3016000973

Entity Name

Precision Medical Products

City/State/Country

Rocklin, CA, US

Establishment Address

3735 Cincinnati Ave Ste 100, Rocklin, CA 95765, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Precision Medical Products Inc. (Owner Number: 10084351)

Owner / Operator Contact Address

2217 Plaza Dr., Rocklin, CA 95765, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cryo8 Back Brace Cryo ROM Knee Cryo Shoulder Circul8 Luxe DVT Prevention Device Circul8One VenaOne Ortho8 Cryo Hip Brace Circul8 Pro VenaPro Vascular Therapy System Defender Pro Defender Circul8 Max Vascular Therapy System Shoulder Arm Sling

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2022-02-13
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2022-02-13
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2025-06-12
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2022-02-13
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2022-02-13
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2022-02-13
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2022-10-24
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2022-02-13
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2025-06-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precision Medical Products 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
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

Similar Registrations

Registration Number	Establishment Name	Location
3015287620	SHENZHEN ZHOUYANG MEDICAL CARE PRODUCT CO., LTD.	Shenzhen Guangdong, CN
8022890	VALENTINE INTL. LTD.	HSICHIH CITY, TAIPEI HSIEN, TW
3003849847	TIEN JIANG ENTERPRISE CO., LTD.	TAINAN CITY, TW
3003829642	PANTYMED S.A.	BUENOS AIRES Buenos Aires, Ciudad Autonoma de, AR
3003573572	Electrostim Medical Services, Inc.	Tampa, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016000973. Last updated year: 2026. Please use registration number 3016000973 when referencing this establishment in official correspondence.