Humac System
FDA 510(k) K952090 · Computer Sports Medicine, Inc.
510(k) numberK952090
Submission
- Device name
- Humac System
- Applicant
- Computer Sports Medicine, Inc.
Waltham, MA, US - Received
- May 3, 1995
- Decision date
- December 11, 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
Other 510(k)s with product code IKK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123746 | Ames Therapy DeviceIKK · Traditional | Ames Technology, Inc. | 05/24/2013SE |
| 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 |
| K950095 | Cybex 770IKK · Traditional | Cybex | 06/21/1995SE |
| 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 |
Questions and answers
When was Humac System cleared by the FDA?
Humac System (K952090) received a 510(k) decision of Substantially Equivalent on December 11, 1995, 222 days after the submission was received.
What is the product code of K952090?
The FDA product code is IKK – System, Isokinetic Testing And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 890.1925.