Wheelchair Safety Belt
FDA 510(k) K771631 · Medical Restraints, Inc.
510(k) numberK771631
Submission
- Device name
- Wheelchair Safety Belt
- Applicant
- Medical Restraints, Inc.
Mchenry, IL, US - Received
- August 26, 1977
- Decision date
- September 12, 1977
- 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 |
|---|---|---|
| K771636 | Body RestraintFMQ · Traditional | 09/30/1977SE |
| K771630 | Limb RestraintFMQ · Traditional | 09/30/1977SE |
| K771629 | Hand RestraintFMQ · Traditional | 09/30/1977SE |
| K771715 | Pelvic Wheelchair RestraintFMQ · Traditional | 09/28/1977SE |
| K771635 | Foot ElevatorFMQ · Traditional | 09/28/1977SE |
| K771634 | Vest RestraintFMQ · Traditional | 09/28/1977SE |
| K771632 | Finger Mitt RestraintFMQ · Traditional | 09/28/1977SE |
| K771676 | Foot Drop BootIQI · Traditional | 09/20/1977SE |
| K771633 | Heel ProtectorFMP · Traditional | 09/12/1977SE |
Questions and answers
When was Wheelchair Safety Belt cleared by the FDA?
Wheelchair Safety Belt (K771631) received a 510(k) decision of Substantially Equivalent on September 12, 1977, 17 days after the submission was received.
What is the product code of K771631?
The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.