Arm Through for Wheelchair BK-6458-01
FDA 510(k) K823637 · Fred Sammons, Inc.
510(k) numberK823637
Submission
- Device name
- Arm Through for Wheelchair BK-6458-01
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- December 6, 1982
- Decision date
- January 21, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNN – Components, Wheelchair
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3920
- Specialty
- Physical Medicine
Other 510(k)s with product code KNN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K211919 | KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKNN · Traditional | Kinetic Innovative Seating System, LLC | 03/04/2022SE |
| K942311 | Dynasty U1-33 AgmKNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942310 | Dynasty GC 12550 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942309 | Dynasty U1-31 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942308 | Dynasty GC 12400 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942312 | Alden Lineage Wheelchair CushionKNN · Traditional | Lewis W. Ward | 05/26/1994SE |
| K942260 | Alden Wheelchair CushionKNN · Traditional | Ward and Assoc. | 05/26/1994SE |
| K933051 | Zero Gravity Wheelchair Components, ModificationKNN · Traditional | General Components Intl., Inc. | 10/12/1993SE |
| K925980 | PMKNN · Traditional | Pathfinder Intl. Corp. | 03/24/1993SE |
| K923942 | Rhombo Medical Rhombo-FillKNN · Traditional | International Medical Products, Inc. | 03/24/1993SE |
More from International Medical Products, Inc.
| 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 |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
Questions and answers
When was Arm Through for Wheelchair BK-6458-01 cleared by the FDA?
Arm Through for Wheelchair BK-6458-01 (K823637) received a 510(k) decision of Substantially Equivalent on January 21, 1983, 46 days after the submission was received.
What is the product code of K823637?
The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.