Walker Folding Adjustable
FDA 510(k) K772271 · Med Fusion Systems, Inc.
510(k) numberK772271
Submission
- Device name
- Walker Folding Adjustable
- Applicant
- Med Fusion Systems, Inc.
Mchenry, IL, US - Received
- December 9, 1977
- Decision date
- December 20, 1977
- 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
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|---|---|---|---|
| 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 |
| K802673 | Knee Brace/StabilizerITQ · Traditional | Omni Scientific, Inc. | 11/12/1980SE |
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| K860803 | IV Filter Extension SetFPB · Traditional | 04/09/1986SE |
| K844313 | Infuset W/Huber NeedleFMI · Traditional | 01/22/1985SE |
| K842984 | Extension Set W/Injection SiteFPA · Traditional | 10/16/1984SE |
| K842143 | Bent Winged Mini-Vol Infusion SetFPA · Traditional | 07/20/1984SE |
Questions and answers
When was Walker Folding Adjustable cleared by the FDA?
Walker Folding Adjustable (K772271) received a 510(k) decision of Substantially Equivalent on December 20, 1977, 11 days after the submission was received.
What is the product code of K772271?
The FDA product code is ITQ – Joint, Knee, External Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.