Cybex 770
FDA 510(k) K950095 · Cybex
510(k) numberK950095
Submission
- Device name
- Cybex 770
- Applicant
- Cybex
Ronkonkoma, NY, US - Received
- January 10, 1995
- Decision date
- June 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code IKK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123746 | Ames Therapy DeviceIKK · Traditional | Ames Technology, Inc. | 05/24/2013SE |
| K952090 | Humac SystemIKK · Traditional | Computer Sports Medicine, Inc. | 12/11/1995SE |
| K951770 | Biodex System 3 Model S3S-AP and Model S3D-3APIKK · Traditional | Biodex Medical Systems, Inc. | 11/16/1995SE |
| K951916 | CC Rider, Model ME180IKK · Traditional | Mettler Electronics Corp. | 10/04/1995SE |
| K942229 | Motivator FTR 2000IKK · Traditional | Hogan & Hartson | 02/27/1995SE |
| K944732 | Dexter IsokineticIKK · Traditional | Cedaron Medical, Inc. | 02/03/1995SE |
| K924414 | The Bte Dynamic LiftIKK · Traditional | Baltimore Therapeutic Equipment Co. | 02/12/1993SE |
| K923350 | Closed Chain Attachment, Model #820-520IKK · Traditional | Biodan Medical Systems, Ltd. | 07/23/1992SE |
| K922772 | Two Position Roll-Up Back Attachment ChairIKK · Traditional | Biodan Medical Systems, Ltd. | 07/13/1992SE |
| K922092 | Single Chair Integral Back AttachmentIKK · Traditional | Biodan Medical Systems, Ltd. | 05/26/1992SE |
More from Biodan Medical Systems, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K905525 | Cybex 6000IKK · Traditional | 02/14/1991SE |
| K881681 | Cybex Back Testing and Rehabilitation SystemIKK · Traditional | 04/25/1990SE |
| K881676 | Linear Lift DeviceIKK · Traditional | 04/25/1990SE |
| K894154 | Metabolic SystemsISD · Traditional | 10/24/1989SE |
| K873599 | Edi 320KQX · Traditional | 10/16/1987SE |
| K872911 | Cybex 340IKK · Traditional | 09/24/1987SE |
| K844368 | Linear Lift DeviceIKK · Traditional | 02/19/1985SE |
| K843739 | Cybex Torso Testing & RehabilitationIKK · Traditional | 11/29/1984SE |
Questions and answers
When was Cybex 770 cleared by the FDA?
Cybex 770 (K950095) received a 510(k) decision of Substantially Equivalent on June 21, 1995, 162 days after the submission was received.
What is the product code of K950095?
The FDA product code is IKK – System, Isokinetic Testing And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 890.1925.