FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇨🇦 Canada
DR KOOL
K Number: K935841
·
Decision Aug 29, 1994
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
11
Review Days
265
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Basic Information
- Device Name
- DR KOOL
- K Number
- K935841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Toronto Medical Corp.
- Date Received
- December 7, 1993
- Decision Date
- August 29, 1994
- Product Code
- ILO
- 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 |
|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | FDA class 2 | Physical Medicine |
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Other Clearances by Toronto Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K950682 | W2 WRIST CPM UNIT | Sep 13, 1995 | Substantially Equivalent |
| K935587 | MULTILINK SHOULDER CPM UNIT | Dec 14, 1994 | Substantially Equivalent |
| K925926 | MOBILIMB T1 TOE CPM UNIT | Mar 22, 1993 | Substantially Equivalent |
| K900466 | MOBILIMB W1 WRIST CPM UNIT | Mar 12, 1990 | Substantially Equivalent |
| K900795 | MOBILIMB L4 LOWER LIMB CPM UNIT | Mar 12, 1990 | Substantially Equivalent |
| K900794 | MOBILIMB H3 HAND CPM UNIT | Mar 2, 1990 | Substantially Equivalent |
| K895720 | MOBILIMB J1 TMJ CPM UNIT | Jan 4, 1990 | Substantially Equivalent |
| K891345 | MOBILIMB CPM SHOULDER UNIT | Apr 24, 1989 | Substantially Equivalent |
| K880686 | TORONTO/MOBILIMB HAND C.P.M. | Feb 26, 1988 | Substantially Equivalent |
| K880336 | MOBILIMB HAND C.P.M. UNIT | Feb 16, 1988 | Substantially Equivalent |