FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE EQUALIZER
K Number: K915369
·
Decision Mar 22, 1993
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
14
Applicant Total
3
Review Days
481
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
- THE EQUALIZER
- K Number
- K915369
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.1615
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Advanced Rehabilitative Technology, Inc.
- Date Received
- November 27, 1991
- Decision Date
- March 22, 1993
- Product Code
- IKE
- 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 |
|---|---|---|---|
| IKE | Transducer, Miniature Pressure | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IKE), ordered by most recent decision date.
SONIC PALPOMETER
FDA 510(k)
FDA Class 1
·Physical Medicine
PRESSORE MONITOR
FDA 510(k)
FDA Class 1
·Physical Medicine
PORTABLE LIMB LOAD MONITOR (BMLLM-100)
FDA 510(k)
FDA Class 1
·Physical Medicine
IOWA ORAL PERFORMANCE ISNTRUMENT
FDA 510(k)
FDA Class 1
·Physical Medicine
FPL
FDA 510(k)
FDA Class 1
·Physical Medicine
TALLEY SD.500 SKIN PRESSURE EVALUATOR
FDA 510(k)
FDA Class 1
·Physical Medicine