510(k) K182682
K182682 is an FDA 510(k) premarket notification submitted by Tissue Regeneration Technologies for the device "OrthoGold 100". The FDA issued a decision of Substantially Equivalent on December 21, 2018. The device falls under product code ISA (Massager, Therapeutic, Electric), a Class I device regulated under 21 CFR 890.5660. Tissue Regeneration Technologies has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2018
- Date Received
- September 26, 2018
- 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