The Bte Dynamic Lift
FDA 510(k) K924414 · Baltimore Therapeutic Equipment Co.
510(k) numberK924414
Submission
- Device name
- The Bte Dynamic Lift
- Applicant
- Baltimore Therapeutic Equipment Co.
Hanover, MD, US - Received
- August 31, 1992
- Decision date
- February 12, 1993
- 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
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| 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 |
| 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 |
|---|---|---|
| K955106 | Bte CPM-20BXB · Traditional | 12/29/1995SE |
| K955105 | Bte CPM-10BXB · Traditional | 12/29/1995SE |
| K925225 | The Bte Vector; Analysis System for the Low BackKQX · Traditional | 06/27/1994SE |
| K933611 | The Bte WS30ISD · Traditional | 06/20/1994SE |
| K895881 | MotionspectLXW · Traditional | 04/10/1990SE |
| K800007 | Work SimulatorBXB · Traditional | 01/21/1980SE |
Questions and answers
When was The Bte Dynamic Lift cleared by the FDA?
The Bte Dynamic Lift (K924414) received a 510(k) decision of Substantially Equivalent on February 12, 1993, 165 days after the submission was received.
What is the product code of K924414?
The FDA product code is IKK – System, Isokinetic Testing And Evaluation, a Class II (moderate risk) device regulated under 21 CFR 890.1925.