CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES

Electrode, Cutaneous

PEPIN MFG., INC.

The following data is part of a premarket notification filed by Pepin Mfg., Inc. with the FDA for Cutaneous Electrotherapy And Recording Electrodes; Tens Electrodes.

Pre-market Notification Details

• Device ID: K070807
• 510k Number: K070807
• Device Name: CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES
• Classification: Electrode, Cutaneous
• Applicant: PEPIN MFG., INC. 800 LEVANGER LANE Stoughton, WI 53589
• Contact: Gary Syring
• Correspondent: Gary Syring; PEPIN MFG., INC. 800 LEVANGER LANE Stoughton, WI 53589
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-26
• Decision Date: 2007-05-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00677346320262	K070807	000
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