SLEEPING WELL, LLC

Address:138 Steeplebush Rd.,Shelburne,VT,05482,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

Device, Anti-Snoring (LRK) (9)

Premarket Exempt

Clear

ZQuiet - 00858522003173 Catalog Number :

Device Description : ZQuiet 2-Pack Contains: (1) ZQuiet Comfort 1 Device, (1) ZQuiet Comfort 2 device ZQuiet 2-Pack Contains: (1) ZQuiet Comfort 1 Device, (1) ZQuiet Comfort 2 device, and (1) Storage Case.

Device Class : 2

Duns Number: 020904101

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

ZQuiet - 00858522003180 Catalog Number :

Device Description : ZQuiet Comfort 1 Device refill unit.

Device Class : 2

Duns Number: 020904101

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

ZQuiet - 00858522003197 Catalog Number :

Device Description : ZQuiet Comfort 2 Refill Unit

Device Class : 2

Duns Number: 020904101

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

ZQuiet S.A. - 00858522003227 Catalog Number :

Device Description : Oral Appliance System for Snoring and Obstructive Sleep ApneaPack contains:(1) S Oral Appliance System for Snoring and Obstructive Sleep ApneaPack contains:(1) Size A mouthpiece- +0 mm advancement(1) Size A mouthpiece- +2 mm advancement(1) Size A mouthpiece- +4 mm advancement(1) Size A mouthpiece- +6 mm advancement(1) Storage case

Device Class : 2

Duns Number: 020904101

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

ZQuiet S.A. - 00858522003234 Catalog Number :

Device Description : ZQuiet S.A. Dental Size A Single Unit

Device Class :

Duns Number: 020904101

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

ZQuiet S.A. - 00858522003241 Catalog Number :

Device Description : ZQuiet S.A. Dental Size B Single Unit

Device Class :

Duns Number: 020904101

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

ZQuiet S.A. - 00858522003258 Catalog Number :

Device Description : ZQuiet S.A. Dental Size C Single Unit

Device Class :

Duns Number: 020904101

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

ZQuiet S.A. - 00858522003265 Catalog Number :

Device Description : ZQuiet S.A. Dental Size D Single Unit

Device Class :

Duns Number: 020904101

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

ZQuiet S.A. - 00858522003289 Catalog Number :

Device Description : Contains 3 of each of the following packaged assemblies:ZQuiet S.A. Dental Size Contains 3 of each of the following packaged assemblies:ZQuiet S.A. Dental Size A Single Unit - DI: 00858522003234ZQuiet S.A. Dental Size B Single Unit - DI: 00858522003241ZQuiet S.A. Dental Size C Single Unit - DI: 00858522003258ZQuiet S.A. Dental Size D Single Unit - DI: 00858522003265

Device Class : 2

Duns Number: 020904101

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

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