FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
K Number: K071710
·
Decision Aug 14, 2007
Classifications
1
FEI Numbers
377
Registration Numbers
377
Same Product Code
81
Applicant Total
8
Review Days
53
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Basic Information
- Device Name
- BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)
- K Number
- K071710
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Johnson & Johnson Consumer Products, Inc.
- Date Received
- June 22, 2007
- Decision Date
- August 14, 2007
- Product Code
- IMD
- 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 |
|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | FDA class 1 | Physical Medicine |
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|---|---|---|---|
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| K941788 | BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP | Oct 3, 1994 | Substantially Equivalent |
| K940536 | BAND-AID(TM) BRAND ADHESIVE BANDAGE | Oct 3, 1994 | Substantially Equivalent |
| K935440 | JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED | Feb 3, 1994 | Substantially Equivalent |
| K840679 | SERENITY CONTOURED ABSORBENT SHIELDS | Mar 22, 1984 | Substantially Equivalent |