FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNIVERSAL POWER FLEX
K Number: K851177
·
Decision Jun 28, 1985
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
159
Applicant Total
30
Review Days
95
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- UNIVERSAL POWER FLEX
- K Number
- K851177
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5380
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Biodynamic Technologies, Inc.
- Date Received
- March 25, 1985
- Decision Date
- June 28, 1985
- Product Code
- BXB
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BXB | Exerciser, Powered | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BXB), ordered by most recent decision date.
G-TRAINER MEDICAL
FDA 510(k)
FDA Class 1
·Physical Medicine
FLO-BOOT
FDA 510(k)
FDA Class 1
·Physical Medicine
ANKLE CALF EXERCISER PHLEBOPUMP
FDA 510(k)
FDA Class 1
·Physical Medicine
E-Z FLEX
FDA 510(k)
FDA Class 1
·Physical Medicine
BTE CPM-20
FDA 510(k)
FDA Class 1
·Physical Medicine
BTE CPM-10
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Biodynamic Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990436 | ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM | Mar 31, 1999 | Substantially Equivalent |
| K990481 | ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM | Mar 17, 1999 | Substantially Equivalent |
| K990513 | ULTIMAX CORTICAL BONE SCREWS | Mar 17, 1999 | Substantially Equivalent |
| K981230 | ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | Jun 1, 1998 | Substantially Equivalent |
| K980102 | BTI HUMERAL INTRAMEDULLARY ROD SYSTEM | Apr 3, 1998 | Substantially Equivalent |
| K974756 | BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS | Mar 12, 1998 | Substantially Equivalent for Some Indications |
| K972403 | BTI CORTICAL BONE SCREWS | Aug 29, 1997 | Substantially Equivalent |
| K970897 | BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | Apr 21, 1997 | Substantially Equivalent |
| K962706 | EZ-FIX CANNULATED SCREW SYSTEM | Nov 13, 1996 | Substantially Equivalent |
| K962987 | EZ-FIX SMALL CANNULATED SCREW SYSTEM | Nov 4, 1996 | Substantially Equivalent |