510(k) K952041
K952041 is an FDA 510(k) premarket notification submitted by Truro'S Ent. for the device "BODYFLEX MASSAGER". The FDA issued a decision of Substantially Equivalent on August 14, 1995. 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
- August 14, 1995
- Date Received
- May 1, 1995
- 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