510(k) K014273
K014273 is an FDA 510(k) premarket notification submitted by S.H.P. Intl. Pty., Ltd. for the device "ACUSTIM". The FDA issued a decision of Substantially Equivalent on June 12, 2002. The device falls under product code BWK (Stimulator, Electro-Acupuncture), a Class U device. S.H.P. Intl. Pty., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2002
- Date Received
- December 27, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electro-Acupuncture
- Device Class
- Class U
- Regulation Number
- Review Panel
- NE
- Submission Type