510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Gemore Technology Co., Ltd.

TAN SHUI New Taipei, TW

GEMORE TECHNOLOGY CO., LTD. appears in FDA device records in TAN SHUI New Taipei, TW. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
14
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 14 510(k) clearances for Gemore Technology Co., Ltd. between 2003 and 2019. The busiest year on record is 2003, with 3. The most recent is 2019, with 1.

Clearances by year, as a table
510(k) clearance decisions for Gemore Technology Co., Ltd., by decision year
YearClearances
20033
20041
20061
20071
20091
20112
20123
20151
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K190988GIM-STIM OTC TENS/EMS SystemNUHSubstantially Equivalent
K150681GEMORE OTC TENSNUHSubstantially Equivalent
K122948GEM-STIM COMBO STIMULATORGZJSubstantially Equivalent
K122944GEMORE TRUE SINE INTERFERENTIAL STIMULATORLIHSubstantially Equivalent
K120569GEMORE TENS SYSTEMGZJSubstantially Equivalent
K102933GEM-TONE BODY TRAINING SYSTEMNGXSubstantially Equivalent
K102926GEMORE MUSCLE CONDITIONER;NGXSubstantially Equivalent
K091833GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.NGXSubstantially Equivalent
K062675GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIESGXYSubstantially Equivalent
K060222LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PPNUHSubstantially Equivalent
K042559GEM-TWIN TENS/ MODELS GM3XY/ZGZJSubstantially Equivalent
K032994GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)GZJSubstantially Equivalent
K032720GEM-STIM TENS, MODELS GM3XY AND GM3AXYGZJSubstantially Equivalent
K032719GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)LIHSubstantially Equivalent

Registered establishments

FDA registered establishments for Gemore Technology Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30041464013004146401GEMORE TECHNOLOGY CO., LTD.11 FL, NO. 29-5, SEC. 2, TAN SHUI New Taipei 251 TW2026and 2 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain