Uniflex Danninger
FDA 510(k) K843309 · Buckman Co., Inc.
510(k) numberK843309
Submission
- Device name
- Uniflex Danninger
- Applicant
- Buckman Co., Inc.
Martinez, CA, US - Received
- August 23, 1984
- Decision date
- October 16, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXB – Exerciser, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5380
- Specialty
- Physical Medicine
Other 510(k)s with product code BXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072887 | G-Trainer MedicalBXB · Traditional | Alter-G, Inc. | 01/25/2008SE |
| K003272 | Flo-BootBXB · Traditional | Discovery Group, LLC | 04/04/2001SE |
| K952975 | Ankle Calf Exerciser PhlebopumpBXB · Traditional | Prevent Products, Inc. | 09/25/1996SE |
| K953456 | E-Z FlexBXB · Traditional | Fluid Motion Biotechnologies, Inc. | 01/26/1996SE |
| K955106 | Bte CPM-20BXB · Traditional | Baltimore Therapeutic Equipment Co. | 12/29/1995SE |
| K955105 | Bte CPM-10BXB · Traditional | Baltimore Therapeutic Equipment Co. | 12/29/1995SE |
| K951028 | Hamex TwoBXB · Traditional | Northern Orthopaedic Products, Inc. | 12/11/1995SE |
| K950755 | Flexmate K500BXB · Traditional | Breg, Inc. | 10/05/1995SE |
| K951029 | Hamex OneBXB · Traditional | Northern Orthopaedic Products, Inc. | 09/15/1995SE |
| K945733 | Aquahab, Model 120-72-101BXB · Traditional | Aquarius Electronics, Inc. | 09/15/1995SE |
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| K974641 | Futurelase 3000/3002 Erbium Laser SystemGEX · Traditional | 06/08/1998SE |
| K964252 | OrthochuckGEY · Traditional | 05/27/1997SE |
| K950099 | Synergy(Tm) Ti Posterior Spinal SystemMNH · Traditional | 01/16/1997SN |
| K960451 | Webb-Morley Spine SystemMNH · Traditional | 04/18/1996SN |
| K950999 | KSF Posterior Spingal Fixator for Severe SpondylolisthesisMNH · Traditional | 01/25/1996SE |
| K945756 | Imagn(Tm) 2000 SystemGKZ · Traditional | 12/19/1995SE |
| K940003 | Volumet CD4 + and CD8 + T Lymphocyte Count Test KitGKZ · Traditional | 10/19/1995SE |
| K951117 | Lihtan 532 LaserGEX · Traditional | 10/18/1995SE |
| K942751 | Vanguard Series Gas RegulatorsCAN · Traditional | 02/09/1995SE |
Questions and answers
When was Uniflex Danninger cleared by the FDA?
Uniflex Danninger (K843309) received a 510(k) decision of Substantially Equivalent on October 16, 1984, 54 days after the submission was received.
What is the product code of K843309?
The FDA product code is BXB – Exerciser, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.