510(k) K843793
K843793 is an FDA 510(k) premarket notification submitted by A-T Surgical Mfg. Co., Inc. for the device "A-T TENS BELT". The FDA issued a decision of Substantially Equivalent on October 12, 1984. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. A-T Surgical Mfg. Co., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 1984
- Date Received
- September 14, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, For Pain Relief
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type