FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIMS CHAIR
K Number: K861632
·
Decision May 27, 1986
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
60
Applicant Total
6
Review Days
28
Basic Information
- Device Name
- SIMS CHAIR
- K Number
- K861632
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1925
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- TWIN CITY SURGICAL, INC.
- Date Received
- April 29, 1986
- Decision Date
- May 27, 1986
- Product Code
- IKK
- 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 |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | FDA class 2 | Physical Medicine |
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Other Clearances by TWIN CITY SURGICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K870767 | THE (CROM) TESTER | Mar 17, 1987 | Substantially Equivalent |
| K830585 | ANVIL RETRACTOR | May 27, 1983 | Substantially Equivalent |
| K820659 | A CALIPER | Mar 19, 1982 | Substantially Equivalent |
| K820660 | A HOOK DRIVER | Mar 19, 1982 | Substantially Equivalent |
| K813067 | SPINAL WRENCH | Nov 24, 1981 | Substantially Equivalent |