FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC
K Number: K923186
·
Decision Sep 9, 1992
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
63
Applicant Total
2
Review Days
71
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
- NEXUS WHEELCHAIR CUSHION/FORMERLY BIOTHOTIC
- K Number
- K923186
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3920
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Roho, Inc.
- Date Received
- June 30, 1992
- Decision Date
- September 9, 1992
- Product Code
- KNN
- 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 |
|---|---|---|---|
| KNN | Components, Wheelchair | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNN), ordered by most recent decision date.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
FDA 510(k)
FDA Class 1
·Physical Medicine
DYNASTY GC 12550 (GELL/CELL)
FDA 510(k)
FDA Class 1
·Physical Medicine
DYNASTY GC 12400 (GELL/CELL)
FDA 510(k)
FDA Class 1
·Physical Medicine
DYNASTY U1-33 AGM
FDA 510(k)
FDA Class 1
·Physical Medicine
DYNASTY U1-31 (GELL/CELL)
FDA 510(k)
FDA Class 1
·Physical Medicine
ALDEN LINEAGE WHEELCHAIR CUSHION
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Roho, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861327 | ROHO HEEL PAD | Jun 2, 1986 | Substantially Equivalent |