Adjustable Polycentric Elbow Hinge
FDA 510(k) K831542 · Fred Sammons, Inc.
510(k) numberK831542
Submission
- Device name
- Adjustable Polycentric Elbow Hinge
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- May 12, 1983
- Decision date
- June 24, 1983
- 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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| 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 |
| 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 |
| K823160 | Rotation BootIQI · Traditional | Warm & Form, Orthopedic Materials | 11/10/1982SE |
More from Warm & Form, Orthopedic Materials
| 510(k) | Device | Decision |
|---|---|---|
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | 05/06/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | 04/01/1988SE |
| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
| K831547 | Raised Toilet Seats & Nail ClippersILS · Traditional | 06/08/1983SE |
Questions and answers
When was Adjustable Polycentric Elbow Hinge cleared by the FDA?
Adjustable Polycentric Elbow Hinge (K831542) received a 510(k) decision of Substantially Equivalent on June 24, 1983, 43 days after the submission was received.
What is the product code of K831542?
The FDA product code is IQI – Orthosis, Limb Brace, a Class I (low risk) device regulated under 21 CFR 890.3475.