510(k) K992372
K992372 is an FDA 510(k) premarket notification submitted by Therapy Equipment, Inc. for the device "THE LEADAWAY". The FDA issued a decision of Substantially Equivalent on October 13, 1999. The device falls under product code IKD (Cable, Electrode), a Class II device regulated under 21 CFR 890.1175.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1999
- Date Received
- July 15, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cable, Electrode
- Device Class
- Class II
- Regulation Number
- 890.1175
- Review Panel
- PM
- Submission Type