FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
K Number: K001860
·
Decision Aug 10, 2000
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
11
Applicant Total
2
Review Days
52
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Basic Information
- Device Name
- PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA
- K Number
- K001860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Homedics, Inc.
- Date Received
- June 19, 2000
- Decision Date
- August 10, 2000
- Product Code
- IMC
- 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 |
|---|---|---|---|
| IMC | Bath, Paraffin | FDA class 2 | Physical Medicine |
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Other Clearances by Homedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012914 | SONICWAVE SONIC PLAQUE REMOVER | Oct 1, 2001 | Substantially Equivalent |