FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RELIEFBAND
K Number: K980333
·
Decision Feb 18, 1998
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
6
Review Days
21
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Basic Information
- Device Name
- RELIEFBAND
- K Number
- K980333
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Woodside Biomedical, Inc.
- Date Received
- January 28, 1998
- Decision Date
- February 18, 1998
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Woodside Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020180 | RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL | Mar 21, 2002 | Substantially Equivalent |
| K994387 | RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL | Mar 16, 2000 | Substantially Equivalent |
| K983907 | RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R | Dec 9, 1999 | Substantially Equivalent |
| K982967 | RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R | Feb 23, 1999 | Substantially Equivalent |
| K982436 | RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R | Oct 8, 1998 | Substantially Equivalent |