Adjust. WEIGHTS-BK5171-05,10,20 Beok
FDA 510(k) K831543 · Fred Sammons, Inc.
510(k) numberK831543
Submission
- Device name
- Adjust. WEIGHTS-BK5171-05,10,20 Beok
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- May 12, 1983
- Decision date
- June 24, 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 |
| K833249 | FitnessION · Traditional | Fitness Equipment Co., Inc. | 11/07/1983SE |
| K832968 | Pedal ExerciserION · Traditional | Maddak, Inc. | 09/29/1983SE |
| 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 |
|---|---|---|
| K880644 | Ultra-Pan for Orthotic Plastics (7262)IRQ · Traditional | 05/06/1988SE |
| K880647 | Adult Perceptual Motor Puzzles (5331-01)HOX · Traditional | 04/01/1988SE |
| K831549 | Arm SlingsILI · Traditional | 06/30/1983SE |
| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
| K831552 | Sorbothane Visco Inner Sole PadKNP · Traditional | 06/08/1983SE |
| K831547 | Raised Toilet Seats & Nail ClippersILS · Traditional | 06/08/1983SE |
Questions and answers
When was Adjust. WEIGHTS-BK5171-05,10,20 Beok cleared by the FDA?
Adjust. WEIGHTS-BK5171-05,10,20 Beok (K831543) received a 510(k) decision of Substantially Equivalent on June 24, 1983, 43 days after the submission was received.
What is the product code of K831543?
The FDA product code is ION – Exerciser, Non-Measuring, a Class I (low risk) device regulated under 21 CFR 890.5370.