510(k) DEN100023
- Device
- AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
- Applicant
- National Center For Pelvic Pain Research Devices,
- 510(k) number
- DEN100023
- Product code
- OSD
- Decision
- Unknown (DENG)
- Decision date
- 2012-11-20
- Date received
- 2010-08-20
- Regulation
- 890.5670
- Classification name
- Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- DAVID WISE
- Address
- 12470 Fiori Ln. Sebastopol CA US 95472 95472
FDA Registration Numbers#
- 3003895865
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OSD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250419 | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) | Plus EV Holdings, Inc. D/B/A Intimate Rose | 2026-07-27 |