Walk N Roll
FDA 510(k) K830784 · Meta-Morris
510(k) numberK830784
Submission
- Device name
- Walk N Roll
- Applicant
- Meta-Morris
Mchenry, IL, US - Received
- March 11, 1983
- Decision date
- May 25, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ITJ – Walker, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3825
- Specialty
- Physical Medicine
Other 510(k)s with product code ITJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K833869 | Child's WalkerITJ · Traditional | Kaye Products, Inc. | 11/29/1983SE |
| K833195 | Umbrella WalkerITJ · Traditional | Convaid Products, Inc. | 10/27/1983SE |
| K830848 | Resi-WalkerITJ · Traditional | Lic-Orthion | 04/05/1983SE |
| K823105 | Resi-WalkerITJ · Traditional | Orthion Corp. | 11/05/1982SE |
| K821404 | Light Weight Aluminum WalkerITJ · Traditional | Manuco Manufacturing Co., Inc. | 05/21/1982SE |
| K820711 | Walk-A-CycleITJ · Traditional | Walk-A-Cycle Division | 04/08/1982SE |
| K811485 | Walker/Crutch BagITJ · Traditional | Fred Sammons, Inc. | 06/16/1981SE |
| K792064 | Delta Rolling Self-Licking WalkerITJ · Traditional | Staricat, Inc. | 10/30/1979SE |
| K790529 | Walking AidITJ · Traditional | Maddak, Inc. | 04/03/1979SE |
| K772049 | Walking AidITJ · Traditional | Guardian Products Co., Inc. | 11/11/1977SE |
Questions and answers
When was Walk N Roll cleared by the FDA?
Walk N Roll (K830784) received a 510(k) decision of Substantially Equivalent on May 25, 1983, 75 days after the submission was received.
What is the product code of K830784?
The FDA product code is ITJ – Walker, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3825.