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Slow Wave

FDA UDI

Class II (US FDA UDI)

by Slow Wave, Inc.

Identity

Trade Name
Slow Wave FDA UDI
Generic Name
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis FDA UDI
Model / Reference
DS8 FDA UDI

Identifiers

Catalog Number
SWDS801 FDA UDI
Primary DI / UDI-DI
00860007686603 FDA UDI
510(k) Number
K191320 FDA UDI
FDA Product Code
LQZ FDA UDI
LRK FDA UDI
GMDN Term
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis

Slow Wave by Slow Wave, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis.

Cleared under the same submission

K191320 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Slow Wave, Inc.

Sources (1)

  • FDA UDI 60bd6d82-a278-4b5f-a158-0b951a259fcc 34 fields · synced Jun 8, 2026