Biodex System 3 Model S3S-AP and Model S3D-3AP
FDA 510(k) K951770 · Biodex Medical Systems, Inc.
510(k) numberK951770
Submission
- Device name
- Biodex System 3 Model S3S-AP and Model S3D-3AP
- Applicant
- Biodex Medical Systems, Inc.
Shirley, NY, US - Received
- April 17, 1995
- Decision date
- November 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IKK – System, Isokinetic Testing And Evaluation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1925
- Specialty
- Physical Medicine
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| K923350 | Closed Chain Attachment, Model #820-520IKK · Traditional | Biodan Medical Systems, Ltd. | 07/23/1992SE |
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| K942694 | Stability System (110V) Model 945-300; Stability System (220V) Model #945-302KHX · Traditional | 03/10/1995SE |
| K940301 | Compex 2IPF · Traditional | 12/28/1994SN |
| K935520 | Upper Body Cycles (110 VOLT)/(220 Volt)BXB · Traditional | 09/16/1994SE |
| K935216 | Semi-Recumbent CyclesBXB · Traditional | 09/16/1994SE |
| K935061 | Lower Body CyclesBXB · Traditional | 09/16/1994SE |
Questions and answers
When was Biodex System 3 Model S3S-AP and Model S3D-3AP cleared by the FDA?
Biodex System 3 Model S3S-AP and Model S3D-3AP (K951770) received a 510(k) decision of Substantially Equivalent on November 16, 1995, 213 days after the submission was received.
What is the product code of K951770?
The FDA product code is IKK – System, Isokinetic Testing And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 890.1925.