FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
K Number: K940160
·
Decision May 27, 1994
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
92
Applicant Total
7
Review Days
135
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Basic Information
- Device Name
- TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
- K Number
- K940160
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5720
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Burke Neutech, Inc.
- Date Received
- January 12, 1994
- Decision Date
- May 27, 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 Burke Neutech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955326 | SPORTS CONTRAST THERAPY SYSTEM ST 7000 | Apr 10, 1996 | Substantially Equivalent for Some Indications |
| K952117 | EPILATOR | Oct 19, 1995 | Substantially Equivalent |
| K943497 | CONTRAST 7000 THERAPY SYSTEM | Jun 7, 1995 | Substantially Equivalent |
| K945803 | THERMAFLEX, MODEL SD 55 C.P.M.H. | May 11, 1995 | Substantially Equivalent |
| K942926 | NEURO-AIDE | Aug 3, 1994 | Substantially Equivalent |
| K926151 | LSI6000 THERMAL THERAPY SYSTEM | May 26, 1993 | Substantially Equivalent |