FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AOT EXTERNAL COMPRESS DEVICE
K Number: K854241
·
Decision Mar 3, 1986
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
3
Applicant Total
3
Review Days
133
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
- AOT EXTERNAL COMPRESS DEVICE
- K Number
- K854241
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Advanced Ortho-Technology, Inc.
- Date Received
- October 21, 1985
- Decision Date
- March 3, 1986
- Product Code
- HWN
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HWN | Instrument, Compression | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWN), ordered by most recent decision date.
ARICULATED TENSION DEVICE SYNTHES TEN
FDA 510(k)
FDA Class 1
·Orthopedic
RIGID TEACHING ATTACHMENT
FDA 510(k)
FDA Class 1
·Orthopedic
FLORIO CPC BAND
FDA 510(k)
FDA Class 1
·Orthopedic