Knee Walker
FDA 510(k) K833870 · Maddak, Inc.
510(k) numberK833870
Submission
- Device name
- Knee Walker
- Applicant
- Maddak, Inc.
Mchenry, IL, US - Received
- November 8, 1983
- Decision date
- November 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ION – Exerciser, Non-Measuring
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5370
- Specialty
- Physical Medicine
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| K120783 | Able-XION · Traditional | Im-Able, Ltd. | 06/20/2012SE |
| K885343 | StandexION · Traditional | Alt, Inc. | 05/01/1989SE |
| K851065 | Gravity King (Deemed Se 87/09/18)ION · Traditional | Unique Functional Products | 06/13/1985SE |
| K840551 | MobilizerION · Traditional | Lossing Orthopedic, Inc. | 03/23/1984SE |
| K833249 | FitnessION · Traditional | Fitness Equipment Co., Inc. | 11/07/1983SE |
| K832968 | Pedal ExerciserION · Traditional | Maddak, Inc. | 09/29/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K831538 | Deluxe Adjust-Angle BOARD-BK4066ION · Traditional | Fred Sammons, Inc. | 06/08/1983SE |
| K831033 | GirexION · Traditional | Lancer Assoc. | 04/27/1983SE |
| K830560 | Exerciser, Passive, Non MeasuringION · Traditional | Kaye Products, Inc. | 03/09/1983SE |
More from Kaye Products, 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 |
| K833177 | Glossectomy Feeding SpoonsILC · Traditional | 10/31/1983SE |
| K833090 | Sensory Roller MassagerISA · Traditional | 10/14/1983SE |
Questions and answers
When was Knee Walker cleared by the FDA?
Knee Walker (K833870) received a 510(k) decision of Substantially Equivalent on November 29, 1983, 21 days after the submission was received.
What is the product code of K833870?
The FDA product code is ION – Exerciser, Non-Measuring, a Class I (low risk) device regulated under 21 CFR 890.5370.