FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EMPI TAPE PATCHES
K Number: K941389
·
Decision Aug 23, 1994
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
60
Review Days
154
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Basic Information
- Device Name
- EMPI TAPE PATCHES
- K Number
- K941389
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Empi
- Date Received
- March 22, 1994
- Decision Date
- August 23, 1994
- Product Code
- KGX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
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| K021100 | 300 PV COMPLETE ELECTROTHERAPY SYSTEM | Jun 18, 2002 | Substantially Equivalent |
| K991991 | DUPEL IONTOPHORESIS SYSTEM | Sep 10, 1999 | Substantially Equivalent |