Mobilizer
FDA 510(k) K840551 · Lossing Orthopedic, Inc.
510(k) numberK840551
Submission
- Device name
- Mobilizer
- Applicant
- Lossing Orthopedic, Inc.
Mchenry, IL, US - Received
- February 8, 1984
- Decision date
- March 23, 1984
- 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 |
| K833870 | Knee WalkerION · Traditional | Maddak, Inc. | 11/29/1983SE |
| 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 |
|---|---|---|
| K900475 | Distrac(Tm) TableITH · Traditional | 05/24/1990SE |
| K864152 | Back Saver Lift Belt/Wheelchair Transfer DeviceILK · Traditional | 02/05/1987SE |
| K862874 | The Towered 90/90 UnitHST · Traditional | 08/07/1986SE |
| K843581 | Prom NaidITH · Traditional | 12/11/1984SE |
| K823236 | Back on Track Inversion Therapy & ExerION · Traditional | 01/21/1983SE |
| K813017 | NecktracHST · Traditional | 11/25/1981SE |
| K802555 | Cottrell 90/90 BacktracHST · Traditional | 10/31/1980SE |
Questions and answers
When was Mobilizer cleared by the FDA?
Mobilizer (K840551) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 44 days after the submission was received.
What is the product code of K840551?
The FDA product code is ION – Exerciser, Non-Measuring, a Class I (low risk) device regulated under 21 CFR 890.5370.