Heat StimPlus

Stimulator, Nerve, Transcutaneous, Over-the-counter

Famidoc Technology Co., Ltd.

The following data is part of a premarket notification filed by Famidoc Technology Co., Ltd. with the FDA for Heat Stimplus.

Pre-market Notification Details

• Device ID: K212918
• 510k Number: K212918
• Device Name: Heat StimPlus
• Classification: Stimulator, Nerve, Transcutaneous, Over-the-counter
• Applicant: Famidoc Technology Co., Ltd. No.212 Yilong Road, Hexi Industrial Zone, Jinxia , Changan Town Dongguan, CN 523853
• Contact: Amos Zou
• Correspondent: Amos Zou; Famidoc Technology Co., Ltd. No.212 Yilong Road, Hexi Industrial Zone, Jinxia , Changan Town Dongguan, CN 523853
• Product Code: NUH
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-14
• Decision Date: 2021-12-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00628176949574	K212918	000
06970389634155	K212918	000
06970389634131	K212918	000