FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLEXION DISTRATION SUPPORT
K Number: K921711
·
Decision Jul 13, 1992
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
14
Applicant Total
3
Review Days
96
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
- FLEXION DISTRATION SUPPORT
- K Number
- K921711
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5925
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Altoona Medical Supply
- Date Received
- April 8, 1992
- Decision Date
- July 13, 1992
- Product Code
- ILZ
- 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 |
|---|---|---|---|
| ILZ | Accessories, Traction | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILZ), ordered by most recent decision date.
VIBRA-TRAC TRACTION TABLE
FDA 510(k)
FDA Class 1
·Physical Medicine
AMX-110, AMX-II AND AMX-III
FDA 510(k)
FDA Class 1
·Physical Medicine
VECTOR BAR SUSPENSION/TRACTION UNIT
FDA 510(k)
FDA Class 1
·Physical Medicine
TRACTION ACCESSORIES
FDA 510(k)
FDA Class 1
·Physical Medicine
SAUNDERS #7080 CERVICAL TRACTION SYS
FDA 510(k)
FDA Class 1
·Physical Medicine
HEAD HALTER
FDA 510(k)
FDA Class 1
·Physical Medicine