Manoy Walking Aid
FDA 510(k) K770166 · Maddak, Inc.
510(k) numberK770166
Submission
- Device name
- Manoy Walking Aid
- Applicant
- Maddak, Inc.
Mchenry, IL, US - Received
- January 25, 1977
- Decision date
- January 28, 1977
- 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 |
| K830784 | Walk N RollITJ · Traditional | Meta-Morris | 05/25/1983SE |
| 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 |
More from Maddak, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841700 | Walk & RollINM · Traditional | 05/11/1984SE |
| 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 |
Questions and answers
When was Manoy Walking Aid cleared by the FDA?
Manoy Walking Aid (K770166) received a 510(k) decision of Substantially Equivalent on January 28, 1977, 3 days after the submission was received.
What is the product code of K770166?
The FDA product code is ITJ – Walker, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3825.