FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCULITE-PPL 5
K Number: K884787
·
Decision Jan 24, 1989
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
0
Applicant Total
3
Review Days
70
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Basic Information
- Device Name
- ACCULITE-PPL 5
- K Number
- K884787
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3910
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medical Alignment Systems
- Date Received
- November 15, 1988
- Decision Date
- January 24, 1989
- Product Code
- INE
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| INE | Sling, Overhead Suspension, Wheelchair | FDA class 1 | Physical Medicine |