Chief SR
FDA 510(k) K940919 · Redman, Inc.
510(k) numberK940919
Submission
- Device name
- Chief SR
- Applicant
- Redman, Inc.
Tucson, AZ, US - Received
- February 24, 1994
- Decision date
- February 3, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- IPL – Wheelchair, Standup
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3900
- Specialty
- Physical Medicine
Other 510(k)s with product code IPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243783 | Walking rehabilitation training electric wheelchair (ZW518)IPL · Traditional | Shenzhen Zuowei Technology Co., Ltd. | 03/12/2025SE |
| K202728 | Action Trackchair HawkIPL · Traditional | Action Manufacturing, Inc. | 02/10/2022SE |
| K203761 | ParaMotionIPL · Traditional | Powerbasetec GmbH | 01/21/2022SE |
| K191334 | Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04…IPL · Traditional | Matia Robotics (Us), Inc. | 05/29/2020SE |
| K190682 | Explorer MiniIPL · Traditional | Permobil AB | 02/27/2020SE |
| K191874 | F5 Corpus VSIPL · Traditional | Permobil AB | 10/25/2019SE |
| K182257 | UPnRIDEIPL · Traditional | Upnride Robotics , Ltd. | 09/12/2019SE |
| K191376 | Modular Power Standing SystemIPL · Traditional | Motion Concepts | 08/13/2019SE |
| K172384 | Quickie(r) Q700-UP MIPL · Traditional | Sunrise Medical (Us), LLC | 01/16/2018SE |
| K163451 | Action Trackstander models TR1816, TR1820, TR2016, and TR2020IPL · Traditional | Action Manufacturing, Inc. | 01/12/2018SE |
More from Action Manufacturing, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940920 | Road SavageITI · Traditional | 02/03/1995SN |
| K940852 | Chief Standup WheelchairIPL · Traditional | 02/03/1995SN |
| K940851 | Red Pack Manlual Power Wheelchair Conversion KitITI · Traditional | 02/03/1995SN |
| K935751 | Geronimo PRITI · Traditional | 02/03/1995SN |
| K935750 | GeronimoITI · Traditional | 02/03/1995SN |
| K935749 | Road WarriorITI · Traditional | 01/13/1995SN |
| K870298 | Redman AccessoriesKNO · Traditional | 02/26/1987SE |
| K870299 | Redman Upholstery Series for WheelchairsKNN · Traditional | 02/10/1987SE |
| K870297 | Dakota Model 102C WheelchairITI · Traditional | 02/10/1987SE |
| K870296 | Mohave Model 102W WheelchairIOR · Traditional | 02/10/1987SE |
Questions and answers
When was Chief SR cleared by the FDA?
Chief SR (K940919) received a 510(k) decision of Substantially Equivalent for Some Indications on February 3, 1995, 344 days after the submission was received.
What is the product code of K940919?
The FDA product code is IPL – Wheelchair, Standup, a Class II (moderate risk) device regulated under 21 CFR 890.3900.