Warm'N Form Sports Supports
FDA 510(k) K821582 · Jerome Medical
510(k) numberK821582
Submission
- Device name
- Warm'N Form Sports Supports
- Applicant
- Jerome Medical
Mchenry, IL, US - Received
- May 28, 1982
- Decision date
- June 10, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IQI – Orthosis, Limb Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
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| K143458 | NeurosplintIQI · Traditional | Neurospectrum, LLC | 08/13/2015SE |
| K052771 | Sensor WalkIQI · Traditional | Otto Bock Healthcare LP | 05/03/2006SE |
| K031576 | Spartan Orthopaedic Wrist Brace, Model SCT-1IQI · Traditional | Surgitech, Inc. | 07/31/2003SE |
| K926391 | Accuflex Dynamic Elbow OrthosisIQI · Traditional | Regulatory & Marketing Services, Inc. | 07/22/1993SE |
| K910974 | Mcconnell Shoulder BraceIQI · Traditional | Mcconnell Orthopedic | 03/21/1991SE |
| K874502 | Gait-Aid Orthopedic InsoleIQI · Traditional | Gait-Aid, Inc. | 11/30/1987SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K831615 | Drop Foot BraceIQI · Traditional | Edward Dilauro, Jr. | 06/15/1983SE |
| K823812 | Various Supports and SplintsIQI · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823113 | Brace-Up All Purpose Wrist BandIQI · Traditional | Arco Matic, Inc. | 11/16/1982SE |
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| K930153 | System III Halo RingJEC · Traditional | 08/06/1993SE |
| K882877 | JMS Cervical Traction Device/Halo DeviceJEC · Traditional | 09/30/1988SE |
| K870053 | Torquedriver WrenchHXC · Traditional | 03/11/1987SE |
| K864969 | JMS Halo Application TrayKDD · Traditional | 02/18/1987SESD |
| K844490 | Traction AccessoriesILZ · Traditional | 02/21/1985SE |
| K822780 | Cervical BraceJEC · Traditional | 10/06/1982SE |
Questions and answers
When was Warm'N Form Sports Supports cleared by the FDA?
Warm'N Form Sports Supports (K821582) received a 510(k) decision of Substantially Equivalent on June 10, 1982, 13 days after the submission was received.
What is the product code of K821582?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.