Traction Table Model #825-200
FDA 510(k) K930259 · Biodan Medical Systems, Ltd.
510(k) numberK930259
Submission
- Device name
- Traction Table Model #825-200
- Applicant
- Biodan Medical Systems, Ltd.
Shirley, NY, US - Received
- January 19, 1993
- Decision date
- March 24, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JFB – Table, Physical Therapy, Multi Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5880
- Specialty
- Physical Medicine
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| K241193 | AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)JFB · Traditional | Marzzan Lucas Jorge | 01/31/2025SE |
| K243644 | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)JFB · Special | Ceragem Co., Ltd. | 01/08/2025SE |
| K243355 | Ceragem Automatic Thermal Massager (CGM-MB-1902)JFB · Special | Ceragem Co., Ltd. | 11/27/2024SE |
| K240168 | N7-SJFB · Traditional | Nuga Medical Co., Ltd. | 09/12/2024SE |
| K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702JFB · Traditional | Ceragem Co., Ltd. | 06/17/2022SE |
| K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702JFB · Traditional | Ceragem Co., Ltd. | 03/18/2021SE |
| K202113 | Ceragem Automatic Thermal Massager, Model CGM-MB-1901JFB · Traditional | Ceragem Co., Ltd. | 03/02/2021SE |
| K153054 | N5-1JFB · Traditional | Nuga Medical Co., Ltd. | 02/05/2016SE |
| K140592 | Ceragem Automatic Thermal MassagerJFB · Traditional | Ceragem International, Inc. | 12/17/2014SE |
More from Ceragem International, Inc.
| 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 |
| 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 |
| K922772 | Two Position Roll-Up Back Attachment ChairIKK · Traditional | 07/13/1992SE |
Questions and answers
When was Traction Table Model #825-200 cleared by the FDA?
Traction Table Model #825-200 (K930259) received a 510(k) decision of Substantially Equivalent on March 24, 1993, 64 days after the submission was received.
What is the product code of K930259?
The FDA product code is JFB – Table, Physical Therapy, Multi Function, a Class II (moderate risk) device regulated under 21 CFR 890.5880.