FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OB HELP ARM
K Number: K823152
·
Decision Nov 5, 1982
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
2
Applicant Total
11
Review Days
16
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Basic Information
- Device Name
- OB HELP ARM
- K Number
- K823152
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Orthion Corp.
- Date Received
- October 20, 1982
- Decision Date
- November 5, 1982
- Product Code
- ILE
- 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 |
|---|---|---|---|
| ILE | Sling, Arm, Overhead Supported | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILE), ordered by most recent decision date.
OB HELP ARM
FDA 510(k)
FDA Class 1
·Physical Medicine
OVERHEAD ARM SLINGS
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 |
| 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 |
| K823154 | SHOWER STOOL W/HANDLES | 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 |