HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
FDA 510(k) clearance K072123 · decided 2008-02-01
Clearance details
- K-number
- K072123
- Device name
- HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
- Applicant
- Biowave Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-08-02
- Decision date
- 2008-02-01
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- GZJ
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.