AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
FDA 510(k) clearance DEN100023 · decided 2012-11-20
Clearance details
- K-number
- DEN100023
- Device name
- AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
- Applicant
- National Center For Pelvic Pain Research Devices,
- Decision
- Unknown
- Date received
- 2010-08-20
- Decision date
- 2012-11-20
- Days to decision
- 823 days
- Clearance type
- Post-NSE
- Product code
- OSD
- Device class
- 2
- Regulation number
- 890.5670
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Sebastopol, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) (K250419) | Plus EV Holdings, Inc. D/B/A Intimate Rose | 2026-07-27 |
Recalls involving this device
No recalls on record reference this clearance.