Walk & Roll
FDA 510(k) K841700 · Maddak, Inc.
510(k) numberK841700
Submission
- Device name
- Walk & Roll
- Applicant
- Maddak, Inc.
Mchenry, IL, US - Received
- April 23, 1984
- Decision date
- May 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- INM – Chair, With Casters
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3100
- Specialty
- Physical Medicine
Other 510(k)s with product code INM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063521 | Nissin Pediatric Series WheelchairINM · Traditional | Nissin Medical, Inc. | 02/05/2007SE |
| K941738 | Stryker 5050 StrechairINM · Traditional | Stryker Medical | 05/06/1994SE |
| K941569 | Caremor ClinerINM · Traditional | Winco, Inc. | 04/26/1994SE |
| K933000 | Reclining Geri Chairs W/Casters & Lap TrayINM · Traditional | Winco, Inc. | 09/30/1993SE |
| K926028 | BenchesINM · Traditional | Theradapt Products, Inc. | 03/24/1993SE |
| K926054 | Eld-Arondak ChairINM · Traditional | Al'S Woodcraft, Inc. | 03/22/1993SE |
| K926053 | Eld-Arondak ChairINM · Traditional | Alert Care, Inc. | 03/22/1993SE |
| K926025 | ChairsINM · Traditional | Theradapt Products, Inc. | 03/22/1993SE |
| K925247 | Stoneheart Roller AidINM · Traditional | Stoneheart, Inc. | 02/12/1993SE |
| K924848 | Kaye Scoot-About, Model SB1INM · Traditional | Kaye Products, Inc. | 02/12/1993SE |
More from Kaye Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841698 | Heat PackIMA · Traditional | 05/10/1984SE |
| K841695 | CrawlerKNL · Traditional | 05/10/1984SE |
| K841697 | Hydro-Thero PadIRT · Traditional | 05/09/1984SE |
| K841693 | Standing Frame · Traditional | 05/09/1984SE |
| K841692 | Prone Stander · Traditional | 05/09/1984SE |
| K841691 | Split Seat Positioning ChairINN · Traditional | 05/09/1984SE |
| K834311 | Night TrainerKPN · Traditional | 03/30/1984SE |
| K833870 | Knee WalkerION · Traditional | 11/29/1983SE |
| K833177 | Glossectomy Feeding SpoonsILC · Traditional | 10/31/1983SE |
| K833090 | Sensory Roller MassagerISA · Traditional | 10/14/1983SE |
Questions and answers
When was Walk & Roll cleared by the FDA?
Walk & Roll (K841700) received a 510(k) decision of Substantially Equivalent on May 11, 1984, 18 days after the submission was received.
What is the product code of K841700?
The FDA product code is INM – Chair, With Casters, a Class I (low risk) device regulated under 21 CFR 890.3100.