Electromedical Products International, Inc.

Address:2201 GARRETT MORRIS PKWY.,Mineral Wells,TX,76067,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (4) Cranial Electrotherapy Stimulator To Treat Depression (JXK) (2) Stimulator, Cranial Electrotherapy (JXK) (1)

Premarket Exempt

No Yes

Clear

Alpha-Stim SCS - 00857869005208 Catalog Number :

Device Description : Alpha-Stim SCS kit

Device Class :

Duns Number: 610954729

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

TruDenta Electrodes - 00857869005215 Catalog Number :

Device Description : TruDenta Electrodes

Device Class :

Duns Number: 610954729

Premarket Exempt : Yes

Product Code : GZJ

Prescription Use : No

Device Count : 1

TruDenta M - 00857869005222 Catalog Number :

Device Description : Alpha-Stim M kit

Device Class :

Duns Number: 610954729

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

TruDenta Earclip Electrode Pad - 00857869005239 Catalog Number :

Device Description : TruDenta Earclip Electrode Pad

Device Class : 3

Duns Number: 610954729

Premarket Exempt : Yes

Product Code : JXK

Prescription Use : No

Device Count : 1

TruDenta Probe Electrode Pad - 00857869005246 Catalog Number :

Device Description : TruDenta Probe Electrode Pad

Device Class : 2

Duns Number: 610954729

Premarket Exempt : Yes

Product Code : GZJ

Prescription Use : No

Device Count : 1

Alpha-Stim M - 00857869005253 Catalog Number :

Device Description : Alpha-Stim M kit - US

Device Class :

Duns Number: 610954729

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Alpha-Stim AID - 00857869005260 Catalog Number :

Device Description : Alpha-Stim AID kit - US

Device Class :

Duns Number: 610954729

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Alpha-Stim Conducting Solution - 00857869005277 Catalog Number :

Device Description : Alpha-Stim Conducting Solution 50 ml

Device Class :

Duns Number: 610954729

Premarket Exempt : Yes

Product Code : GZJ, JXK

Prescription Use : No

Device Count : 1

Alpha-Stim Conducting Solution - 00857869005284 Catalog Number :

Device Description : Alpha-Stim Conducting Solution 250 ml

Device Class :

Duns Number: 610954729

Premarket Exempt : Yes

Product Code : GZJ, JXK

Prescription Use : No

Device Count : 1

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