Universal Power Flex
FDA 510(k) K851177 · Biodynamic Technologies, Inc.
510(k) numberK851177
Submission
- Device name
- Universal Power Flex
- Applicant
- Biodynamic Technologies, Inc.
Arlington, VA, US - Received
- March 25, 1985
- Decision date
- June 28, 1985
- 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 |
More from Aquarius Electronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K990436 | Ultimax Trochanteric Intramedullary Rod SystemHSB · Traditional | 03/31/1999SE |
| K990513 | Ultimax Cortical Bone ScrewsHWC · Traditional | 03/17/1999SE |
| K990481 | Ultimax Distal Radial (Volar) Locking Plate SystemHRS · Traditional | 03/17/1999SE |
| K981230 | Ultimax Distal Femoral Intramedullary Rod SystemHSB · Traditional | 06/01/1998SE |
| K980102 | Bti Humeral Intramedullary Rod SystemHSB · Traditional | 04/03/1998SE |
| K974756 | Bti Large (7.0MM) Cannulated Transfixing ScrewsHWC · Traditional | 03/12/1998SN |
| K972403 | Bti Cortical Bone ScrewsHWC · Traditional | 08/29/1997SE |
| K970897 | Bti Distal Femoral Intramedullary Rod SystemHSB · Traditional | 04/21/1997SE |
| K962706 | Ez-Fix Cannulated Screw SystemHWC · Traditional | 11/13/1996SE |
| K962987 | Ez-Fix Small Cannulated Screw SystemHWC · Traditional | 11/04/1996SE |
Questions and answers
When was Universal Power Flex cleared by the FDA?
Universal Power Flex (K851177) received a 510(k) decision of Substantially Equivalent on June 28, 1985, 95 days after the submission was received.
What is the product code of K851177?
The FDA product code is BXB – Exerciser, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.