Fitness
FDA 510(k) K833249 · Fitness Equipment Co., Inc.
510(k) numberK833249
Submission
- Device name
- Fitness
- Applicant
- Fitness Equipment Co., Inc.
Mchenry, IL, US - Received
- September 23, 1983
- Decision date
- November 7, 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
Other 510(k)s with product code ION
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K833870 | Knee WalkerION · Traditional | Maddak, Inc. | 11/29/1983SE |
| 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 |
Questions and answers
When was Fitness cleared by the FDA?
Fitness (K833249) received a 510(k) decision of Substantially Equivalent on November 7, 1983, 45 days after the submission was received.
What is the product code of K833249?
The FDA product code is ION – Exerciser, Non-Measuring, a Class I (low risk) device regulated under 21 CFR 890.5370.