FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BATHTUB GRAB BAR
K Number: K821009
·
Decision Apr 21, 1982
Classifications
1
FEI Numbers
301
Registration Numbers
301
Same Product Code
30
Applicant Total
8
Review Days
9
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Basic Information
- Device Name
- BATHTUB GRAB BAR
- K Number
- K821009
- 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
- April 12, 1982
- Decision Date
- April 21, 1982
- 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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Other Clearances by Guardian Products Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K915108 | FOLDING WHEELCHAIR | Jan 13, 1992 | Substantially Equivalent |
| K842650 | WALL GRAB BARS 98130-98136 | Aug 10, 1984 | 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 |
| K790299 | FOREARM-CANE | Feb 21, 1979 | Substantially Equivalent |
| K772049 | WALKING AID | Nov 11, 1977 | Substantially Equivalent |