TENS AND POWERED MUSCLE STIMULATOR

Stimulator, Nerve, Transcutaneous, Over-the-counter

SHENZHEN AS-TEC TECHNOLOGY CO., LTD

The following data is part of a premarket notification filed by Shenzhen As-tec Technology Co., Ltd with the FDA for Tens And Powered Muscle Stimulator.

Pre-market Notification Details

• Device ID: K143268
• 510k Number: K143268
• Device Name: TENS AND POWERED MUSCLE STIMULATOR
• Classification: Stimulator, Nerve, Transcutaneous, Over-the-counter
• Applicant: SHENZHEN AS-TEC TECHNOLOGY CO., LTD 2C XINGBAOYI INDUSTRIAL BLD., HOUTING VILLAGE, BEITING RD., SHAJING Shenzhen, CN 518104
• Contact: Connie Li
• Correspondent: Doris Dong; SHANGHAI CV TECHNOLOGY CO., LTD ROOM 1706 YUESHA BUILDING, NO.128 SONGLE RD., SONGJIANG AREA Shanghai, CN 201600
• Product Code: NUH
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-11-13
• Decision Date: 2015-07-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
16970890320650	K143268	000
16970890320193	K143268	000
16970890320209	K143268	000
16970890320216	K143268	000
16970890320223	K143268	000
16970890320254	K143268	000
16970890320407	K143268	000
16970890320469	K143268	000
16970890320445	K143268	000
16970890320452	K143268	000
06970890320424	K143268	000
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16970890320476	K143268	000
06970890320301	K143268	000
06970890320325	K143268	000
16970890320186	K143268	000
16970890320162	K143268	000
16970890320636	K143268	000
16970890320643	K143268	000
10858759005428	K143268	000
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16970890320599	K143268	000
16970890320230	K143268	000
16970890320247	K143268	000
16970890320582	K143268	000
16970890320551	K143268	000
16970890320568	K143268	000
16970890320575	K143268	000
16970890320131	K143268	000
16970890320391	K143268	000
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10810038636044	K143268	000
10810038634842	K143268	000
06970890326287	K143268	000
10855944007908	K143268	000
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06970890326463	K143268	000
06970890327101	K143268	000
06970890327062	K143268	000
00697089032723	K143268	000
06970890320008	K143268	000
06970890320009	K143268	000
06970890320010	K143268	000
06970890329283	K143268	000
06970890329541	K143268	000
10810038630257	K143268	000
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10810038633357	K143268	000
16970890320292	K143268	000
00862081000375	K143268	000
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06970890320080	K143268	000
06970890320097	K143268	000
06970890320103	K143268	000
06970890321704	K143268	000
06970890329540	K143268	000
00862081000320	K143268	000