METTLER ELECTRONICS CORP.

Address:1333 SOUTH CLAUDINA ST.,ANAHEIM,CA,92805,US

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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

Lamp, infrared, therapeutic heating (ILY) (5) STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF (GZJ) (3) Stimulator, muscle, powered (IPF) (3) INTERFERENTIAL CURRENT THERAPY (LIH) (2) STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT (IMG) (1) Media,coupling,ultrasound (MUI) (1) ELECTRODE, CUTANEOUS (GXY) (1) DIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT (IMJ) (1) Pump, infusion (FRN) (1)

Premarket Exempt

Clear

V Trode, 2" square - 00816864020319 Catalog Number : 2705

Device Description : 2" square electrodes with lead wires, 4 electrodes/pkg.

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

Sonigel Lotion with Aloe Vera - 00816864020326 Catalog Number : 1863

Device Description : Sonigel 1863 (1 x 1 gallon)

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : MUI

Prescription Use : No

Device Count : 1

Trio*Stim 215 - 00816864020401 Catalog Number : ME 215

Device Description : Stimulator, nerve, transcutaneous, for pain relief

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : GZJ, IPF

Prescription Use : Yes

Device Count : 1

Laser Sys*Stim 540 - 00816864020425 Catalog Number : ME 540

Device Description : Therapeutic laser and light therapy

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Silberg T.P.S. - 00816864020432 Catalog Number : ME 800

Device Description : Silberg Tissue Preparation System

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : IMG, FRN

Prescription Use : Yes

Device Count : 1

Drum Applicator 3980 - 00816864020531 Catalog Number : 3980

Device Description : 14 cm diameter drum applicator

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : IMJ

Prescription Use : No

Device Count : 1

Laser Applicator 5401 - 00816864020548 Catalog Number : 5401

Device Description : 785 nm laser applicator

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

Cluster Applicator 5402 - 00816864020555 Catalog Number : 5402

Device Description : 660/950 nm SLD/LED cluster applicator

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : ILY

Prescription Use : No

Device Count : 1

Laser Applicator 2401 - 00816864020579 Catalog Number : 2401

Device Description : Laser applicator, 785 nm

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : IPF, LIH, ILY, GZJ

Prescription Use : No

Device Count : 1

Cluster Applicator 2402 - 00816864020586 Catalog Number : 2402

Device Description : Cluster applicator, 600/950 nm

Device Class : 2

Duns Number: 008513913

Premarket Exempt : No

Product Code : GZJ, ILY, LIH, IPF

Prescription Use : No

Device Count : 1

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