510(k) K933194
K933194 is an FDA 510(k) premarket notification submitted by Progressive Electrical Therapeutics for the device "THE SIGNATURE SERIES, IMC IV". The FDA issued a decision of Substantially Equivalent on July 13, 1994. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Progressive Electrical Therapeutics has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 1994
- Date Received
- July 1, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type