Flexion-Braking Knee-Shin Assembly
FDA 510(k) K761314 · Hosmer Dorrance Corp.
510(k) numberK761314
Submission
- Device name
- Flexion-Braking Knee-Shin Assembly
- Applicant
- Hosmer Dorrance Corp.
Mchenry, IL, US - Received
- December 23, 1976
- Decision date
- January 10, 1977
- 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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| K840551 | MobilizerION · Traditional | Lossing Orthopedic, Inc. | 03/23/1984SE |
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| 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 |
More from Lancer Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K822632 | Elbow ProsthesisIRE · Traditional | 09/14/1982SE |
| K821704 | Fracture BracingIQI · Traditional | 06/24/1982SE |
| K801788 | Humerous Fracture Brace, Ulna FractureIQI · Traditional | 08/07/1980SE |
| K780892 | Fracture BracingITQ · Traditional | 06/13/1978SE |
| K780891 | Post-Operative Hip OrthosisITS · Traditional | 06/13/1978SE |
| K780890 | Capp Terminal DeviceIQX · Traditional | 06/13/1978SE |
| K761313 | 4-BAR Knee-Shin Set-UpION · Traditional | 01/10/1977SE |
| K761312 | Orthotic BracingIQI · Traditional | 01/10/1977SE |
Questions and answers
When was Flexion-Braking Knee-Shin Assembly cleared by the FDA?
Flexion-Braking Knee-Shin Assembly (K761314) received a 510(k) decision of Substantially Equivalent on January 10, 1977, 18 days after the submission was received.
What is the product code of K761314?
The FDA product code is ION – Exerciser, Non-Measuring, a Class I (low risk) device regulated under 21 CFR 890.5370.