510(k) K842268
K842268 is an FDA 510(k) premarket notification submitted by I-Rep, Inc. for the device "VACUPULSE VACUUM UNIT". The FDA issued a decision of Substantially Equivalent on July 20, 1984. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. I-Rep, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1984
- Date Received
- June 8, 1984
- 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