FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARM SLING, POUCH TYPE
K Number: K812477
·
Decision Sep 14, 1981
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
20
Applicant Total
51
Review Days
14
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Basic Information
- Device Name
- ARM SLING, POUCH TYPE
- K Number
- K812477
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3640
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Maddak, Inc.
- Date Received
- August 31, 1981
- Decision Date
- September 14, 1981
- Product Code
- ILI
- 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 |
|---|---|---|---|
| ILI | Sling, Arm | FDA class 1 | Physical Medicine |
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Other Clearances by Maddak, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841700 | WALK & ROLL | May 11, 1984 | Substantially Equivalent |
| K841695 | CRAWLER | May 10, 1984 | Substantially Equivalent |
| K841698 | HEAT PACK | May 10, 1984 | Substantially Equivalent |
| K841697 | HYDRO-THERO PAD | May 9, 1984 | Substantially Equivalent |
| K841692 | PRONE STANDER | May 9, 1984 | Substantially Equivalent |
| K841691 | SPLIT SEAT POSITIONING CHAIR | May 9, 1984 | Substantially Equivalent |
| K841693 | STANDING FRAME | May 9, 1984 | Substantially Equivalent |
| K834311 | NIGHT TRAINER | Mar 30, 1984 | Substantially Equivalent |
| K833870 | KNEE WALKER | Nov 29, 1983 | Substantially Equivalent |
| K833177 | GLOSSECTOMY FEEDING SPOONS | Oct 31, 1983 | Substantially Equivalent |