FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHOWER STOOL W/HANDLES
K Number: K830852
·
Decision Apr 5, 1983
Classifications
1
FEI Numbers
301
Registration Numbers
301
Same Product Code
30
Applicant Total
17
Review Days
19
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Basic Information
- Device Name
- SHOWER STOOL W/HANDLES
- K Number
- K830852
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Lic-Orthion
- Date Received
- March 17, 1983
- Decision Date
- April 5, 1983
- Product Code
- ILS
- 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 |
|---|---|---|---|
| ILS | Adaptor, Hygiene | FDA class 1 | Physical Medicine |
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| K854730 | DAISY (ABSORBENT INCONTINENCE SHIELD) | Feb 6, 1986 | Substantially Equivalent |
| K854729 | ADAM (ABSORBENT INCONTINENCE SHIELD) | Feb 6, 1986 | Substantially Equivalent |
| K851470 | BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR | Jun 12, 1985 | Substantially Equivalent |
| K851471 | TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR | Jun 12, 1985 | Substantially Equivalent |
| K843233 | ANATOM SYSTEM | Oct 25, 1984 | Substantially Equivalent |
| K843234 | CITOMAT AUTOCLAVES | Oct 25, 1984 | Substantially Equivalent |
| K830853 | LAVATORY SEAT HEIGHTENER | Jun 8, 1983 | Substantially Equivalent |
| K830849 | OB TILT | Apr 5, 1983 | Substantially Equivalent |