Knee Brace/Stabilizer
FDA 510(k) K802673 · Omni Scientific, Inc.
510(k) numberK802673
Submission
- Device name
- Knee Brace/Stabilizer
- Applicant
- Omni Scientific, Inc.
Mchenry, IL, US - Received
- October 27, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ITQ – Joint, Knee, External Brace
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3475
- Specialty
- Physical Medicine
Other 510(k)s with product code ITQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831044 | Limited Motion Functional Knee BraceITQ · Traditional | Orthopedic Systems, Inc. | 06/24/1983SE |
| K831310 | Brace C.T.ITQ · Traditional | Innovation Sports, Inc. | 05/16/1983SE |
| K823658 | Deluxe Knee Immobilizer(Universal)ITQ · Traditional | Warm & Form, Orthopedic Materials | 12/30/1982SE |
| K823397 | Anatomic Fracture BraceITQ · Traditional | Orthopedic Systems, Inc. | 11/29/1982SE |
| K823159 | Deluxe Knee ImmobilizerITQ · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
| K812423 | Neoprene Knee SupportITQ · Traditional | Surgical Appliance Industries, Inc. | 09/14/1981SE |
| K812094 | Aircast Pneumatic Knee BraceITQ · Traditional | Aircast, Inc. | 08/13/1981SE |
| K811689 | Cylinder Knee Cast/SplintITQ · Traditional | Surgical Appliance Industries, Inc. | 06/25/1981SE |
| K810222 | Limb OrhtosisITQ · Traditional | Medical Design & Manufacturing Corp. | 02/04/1981SE |
| K780892 | Fracture BracingITQ · Traditional | Hosmer Dorrance Corp. | 06/13/1978SE |
Questions and answers
When was Knee Brace/Stabilizer cleared by the FDA?
Knee Brace/Stabilizer (K802673) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 16 days after the submission was received.
What is the product code of K802673?
The FDA product code is ITQ – Joint, Knee, External Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.