Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008216220

FEI Number

3008216220

Entity Name

ORTHOCOR MEDICAL INC.

City/State/Country

Blaine, MN, US

Establishment Address

8611 W 35W Service Dr. NE, suite 180, Blaine, MN 55449, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Caerus Medical (Owner Number: 10029459)

Owner / Operator Contact Address

8611 W 35W Service Dr. NE, suite 180, Blaine, MN 55449, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121702

PMA Number

N/A

All Registered Proprietary Names

Avenue 8 Koolflex Wrist Support Truncal/Orthosis Brace Switch Hitter Universal Thumb Spica and Wrist Orthosis Lumbar Brace Elastic Lumbar Support With Spandex Pocket Lumbosacral Corset Orthosis Lumbosacral Corset Koolflex Knee Orthosis with Positive Control Distal Strap knee brace Koolflex Patella Slip-on Knee Orthosis Kneemate Koolflex Wraparound Orthosis Koolflex Knee Sleeve with Stays HeatPods Orthocor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-02-27
ILX	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5290	2025-02-27
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2025-02-27
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2024-11-11
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2012-09-25
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2024-11-11
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2012-09-25
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2009-05-15
ILX	Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5290	2017-11-17

Official Correspondent

David Rothkopf

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Caerus Medical

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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

Similar Registrations

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3017103360	RAIN EYE DROPS LLC	Wilmington, DE, US
3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008216220. Last updated year: 2026. Please use registration number 3008216220 when referencing this establishment in official correspondence.