FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WALL GRAB BARS 98130-98136
K Number: K842650
·
Decision Aug 10, 1984
Classifications
1
FEI Numbers
282
Registration Numbers
282
Same Product Code
17
Applicant Total
8
Review Days
31
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Basic Information
- Device Name
- WALL GRAB BARS 98130-98136
- K Number
- K842650
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Guardian Products Co., Inc.
- Date Received
- July 10, 1984
- Decision Date
- August 10, 1984
- 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.
TRICYCLES
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TUB TRANSFER BENCH BK6481
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BOARD TO TRANSFER PARALYZED PATIENT FROM
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BATH TUB SAFETY BAR
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·Physical Medicine
CHAIR OR BED LEG EXTENDERS
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FDA Class 1
·Physical Medicine
SHOWER STOOL W/HANDLES
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Guardian Products Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915108 | FOLDING WHEELCHAIR | Jan 13, 1992 | Substantially Equivalent |
| K842649 | BATH TUB TRANSFER CHAIR | Aug 10, 1984 | Substantially Equivalent |
| K842651 | COMMODE CHAIR 98200 | Aug 7, 1984 | Substantially Equivalent |
| K821010 | BATHTUB TRANSFER BENCH | Apr 21, 1982 | Substantially Equivalent |
| K821009 | BATHTUB GRAB BAR | Apr 21, 1982 | Substantially Equivalent |
| K790299 | FOREARM-CANE | Feb 21, 1979 | Substantially Equivalent |
| K772049 | WALKING AID | Nov 11, 1977 | Substantially Equivalent |