Data / Medical devices / United States / Orthocor Medical Inc.
Orthocor Medical Inc.: FDA-registered device maker in Blaine, MN, United States, 2 510(k) clearances
Orthocor Medical Inc. is registered with the FDA (registration 3008216220) in Blaine, MN, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 18, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008216220
- Address
- 8611 W 35W Service Dr. NE suite 180, Blaine, MN, United States, 55449
- Owner or operator
- Caerus Medical (10029459)
- Roles
- Manufacturer
- First device listed
- May 15, 2009
- Registered through
- 2026
- Brand names listed
- Avenue 8, Cubital Tunnel Elbow Support, Elastic Lumbar Support With Spandex Pocket, Gel Bow Universal Tennis Elbow Strap, HeatPods, Kneemate Koolflex Wraparound Orthosis, Koolflex Knee Orthosis with Positive Control Distal Strap, Koolflex Knee Sleeve with Stays and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | ILX | 2 | Manufacturer | accessdata.fda.gov |
| Joint, Knee, External Brace | ITQ | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 18, 2024 | K241395 | Active System; Avenue8 | ILX | Substantially Equivalent | Caerus Corporation | accessdata.fda.gov |
| May 6, 2013 | K121702 | ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE | ILX | Substantially Equivalent | Orthocor Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Lumbo-Sacral
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- All makers of Pad, Heating, Powered
- All makers of Orthosis, Limb Brace
- All makers of Orthosis, Lumbar
Updated December 18, 2024. 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.