FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BioWave BioWraps
K Number: K203158
·
Decision Jul 8, 2021
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
8
Review Days
259
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Basic Information
- Device Name
- BioWave BioWraps
- K Number
- K203158
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biowave Corporation
- Date Received
- October 22, 2020
- Decision Date
- July 8, 2021
- Product Code
- GXY
- 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
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Other Clearances by Biowave Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K261522 | BioWave BioWraps | Jun 3, 2026 | Substantially Equivalent |
| K210202 | BioWaveGO RX | Feb 24, 2021 | Substantially Equivalent |
| K180943 | BioWaveGO | Aug 17, 2018 | Substantially Equivalent |
| K152437 | BiowaveHOME Neuromodulation Pain Therapy Device | Sep 25, 2015 | Substantially Equivalent |
| K072123 | HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE | Feb 1, 2008 | Substantially Equivalent |
| K061166 | DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM | Aug 15, 2006 | Substantially Equivalent |
| K052289 | DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE | Dec 13, 2005 | Substantially Equivalent |