Single Chair Integral Back Attachment
FDA 510(k) K922092 · Biodan Medical Systems, Ltd.
510(k) numberK922092
Submission
- Device name
- Single Chair Integral Back Attachment
- Applicant
- Biodan Medical Systems, Ltd.
Shirley, NY, US - Received
- May 5, 1992
- Decision date
- May 26, 1992
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K932153 | Thyroid Uptake System & Atomlab 950 Med. SpectromeIZD · Traditional | 09/07/1993SE |
| K930261 | RTM Rehabilitation Treadmill, Model #945-200IOL · Traditional | 05/26/1993SE |
| K930262 | Treatment Table, Model #825-100INO · Traditional | 03/29/1993SE |
| K930259 | Traction Table Model #825-200JFB · Traditional | 03/24/1993SE |
| K926083 | Nuclear Patient Sanning Tables, Various TypesIYX · Traditional | 02/12/1993SE |
| K926082 | Cardiac Stress Table, 056-180/UNIV Roll Stress AttIZI · Traditional | 12/30/1992SE |
| K922591 | Urological C-Arm Table, Model #056-450IXR · Traditional | 11/27/1992SE |
| K922605 | Trendelenburg Ultrasound Table, Model # 056-603IYO · Traditional | 10/20/1992SE |
| K922604 | Deluxe Adjustable Height Ultrasound TableIYO · Traditional | 10/20/1992SE |
| K923350 | Closed Chain Attachment, Model #820-520IKK · Traditional | 07/23/1992SE |
Questions and answers
When was Single Chair Integral Back Attachment cleared by the FDA?
Single Chair Integral Back Attachment (K922092) received a 510(k) decision of Substantially Equivalent on May 26, 1992, 21 days after the submission was received.
What is the product code of K922092?
The FDA product code is IKK – System, Isokinetic Testing And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 890.1925.