510(k) K053225
K053225 is an FDA 510(k) premarket notification submitted by Lpg One, Inc. for the device "CELLU M6 KEYMODULE I". The FDA issued a decision of Substantially Equivalent on November 6, 2006. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2006
- Date Received
- November 17, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Therapeutic, Electric
- Device Class
- Class I
- Regulation Number
- 890.5660
- Review Panel
- PM
- Submission Type