Removable Battery Power System
FDA 510(k) K885106 · Rolcontrol Products, Co., Inc.
510(k) numberK885106
Submission
- Device name
- Removable Battery Power System
- Applicant
- Rolcontrol Products, Co., Inc.
Camarillo, CA, US - Received
- December 12, 1988
- Decision date
- December 27, 1988
- 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 |
|---|---|---|
| K885105 | Sliding Arm SupportKNN · Traditional | 12/27/1988SE |
| K885104 | Laydown Arm Support MechanismKNN · Traditional | 12/27/1988SE |
| K885103 | 1600 Light Touch ControlITI · Traditional | 12/27/1988SE |
| K883679 | Wheels-Off Quick Release Axle SystemKNN · Traditional | 09/13/1988SE |
| K883678 | 4007 Model Recliner ControllerITI · Traditional | 09/13/1988SE |
| K883674 | Manual Swing ArmITI · Traditional | 09/13/1988SE |
| K883673 | Power Mechanical ReclinerITI · Traditional | 09/13/1988SE |
| K883672 | Paralyzed Veterans of America Power ReclinerITI · Traditional | 09/13/1988SE |
| K883671 | 805 Power Chair Conversion SystemITI · Traditional | 09/13/1988SE |
Questions and answers
When was Removable Battery Power System cleared by the FDA?
Removable Battery Power System (K885106) received a 510(k) decision of Substantially Equivalent on December 27, 1988, 15 days after the submission was received.
What is the product code of K885106?
The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.