TENS STIMULATOR, MODELS 2800 AND 3000

Stimulator, Nerve, Transcutaneous, For Pain Relief

KOALATY PRODUCTS, INC.

The following data is part of a premarket notification filed by Koalaty Products, Inc. with the FDA for Tens Stimulator, Models 2800 And 3000.

Pre-market Notification Details

Device IDK102014
510k NumberK102014
Device Name:TENS STIMULATOR, MODELS 2800 AND 3000
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant KOALATY PRODUCTS, INC. # 3 BLDG, XILIYANGGUANG IND ES XILIAOBAIMANG Shenzhen, Guangdong,  CN 518108
ContactKang Jiang Ping
CorrespondentJeffrey D Rongero
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-07-16
Decision Date2010-08-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
80813520010772 K102014 000
80092237615955 K102014 000
80092237616402 K102014 000
80092237618703 K102014 000
80092237618734 K102014 000
80092237618765 K102014 000
00858688006261 K102014 000
00858688006285 K102014 000
00858688006704 K102014 000
80092237612879 K102014 000

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