FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
TOTALLY COOL(TM) TC-1
K Number: K943844
·
Decision Feb 9, 1995
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
2
Review Days
237
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Basic Information
- Device Name
- TOTALLY COOL(TM) TC-1
- K Number
- K943844
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Electro Science Technologies, Inc.
- Date Received
- June 17, 1994
- Decision Date
- February 9, 1995
- 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 Electro Science Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942882 | TOTALLY COOL(TM) TC-2 | Feb 9, 1995 | Substantially Equivalent for Some Indications |