FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHOWER STOOL W/HANDLES
K Number: K823154
·
Decision Nov 5, 1982
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
17
Applicant Total
11
Review Days
16
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Basic Information
- Device Name
- SHOWER STOOL W/HANDLES
- K Number
- K823154
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Orthion Corp.
- Date Received
- October 20, 1982
- Decision Date
- November 5, 1982
- Product Code
- IKX
- 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 |
|---|---|---|---|
| IKX | Aid, Transfer | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IKX), ordered by most recent decision date.
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FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Orthion Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K832546 | MARK V HIGH VOLTAGE GALVANIC STIMULATORR | Oct 14, 1983 | Substantially Equivalent |
| K823149 | OB TILT TABLE | Nov 5, 1982 | Substantially Equivalent |
| K823152 | OB HELP ARM | Nov 5, 1982 | Substantially Equivalent |
| K823151 | OB TRIPP TRANSPORT CHAIR | Nov 5, 1982 | Substantially Equivalent |
| K823150 | SESAM TREATMENT TABLE | Nov 5, 1982 | Substantially Equivalent |
| K823156 | COLLAPSABLE LAVATORY HEIGHTENER | Nov 5, 1982 | Substantially Equivalent |
| K823105 | RESI-WALKER | Nov 5, 1982 | Substantially Equivalent |
| K823155 | LAVATORY SEAT HEIGHTENER | Nov 5, 1982 | Substantially Equivalent |
| K823153 | BATH TUB SEAT & BATH BOARD | Nov 5, 1982 | Substantially Equivalent |
| K812701 | ORTHO-THERM INFRARED SENSOR | Oct 13, 1981 | Substantially Equivalent |