510(k) K881080
K881080 is an FDA 510(k) premarket notification submitted by Ferguson Medical for the device "DERMAPOINTS MODEL 100 THERAPEUTIC MASSAGER". The FDA issued a decision of Substantially Equivalent on July 21, 1988. The device falls under product code LYG (Massager, Therapeutic, Manual), a Class I device regulated under 21 CFR 890.5660. Ferguson Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1988
- Date Received
- March 14, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Therapeutic, Manual
- Device Class
- Class I
- Regulation Number
- 890.5660
- Review Panel
- PM
- Submission Type