Isostation Shoulder Machine
FDA 510(k) K841849 · Isotechnologies, Inc.
510(k) numberK841849
Submission
- Device name
- Isostation Shoulder Machine
- Applicant
- Isotechnologies, Inc.
Walker, MI, US - Received
- May 3, 1984
- Decision date
- May 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Biodan Medical Systems, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K933063 | Isotechnologies Back Tracker and Back Works SoftwaKQX · Traditional | 01/27/1994SE |
| K912175 | Isotechnologies Liftstation & Liftworks SoftwareINK · Traditional | 06/07/1991SE |
| K854621 | Isostation Knee Machine (K-100) · Traditional | 03/07/1986SE |
| K844060 | Isostation Ankle/Subtalar Machine A-100IKK · Traditional | 11/23/1984SE |
| K842296 | Isostation Lower Back MachineIKK · Traditional | 06/22/1984SE |
Questions and answers
When was Isostation Shoulder Machine cleared by the FDA?
Isostation Shoulder Machine (K841849) received a 510(k) decision of Substantially Equivalent on May 14, 1984, 11 days after the submission was received.
What is the product code of K841849?
The FDA product code is IKK – System, Isokinetic Testing And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 890.1925.