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ComfortWave

FDA UDI

Class I (US FDA UDI)

by Sidmar Manufacturing, Inc.

Identity

Trade Name
ComfortWave FDA UDI
Generic Name
Dry hydro-massage system FDA UDI
Device Name
ComfortWave Hydromassage Table, S10, Teal, Right Hand Control, 120 volt, 60 hertz FDA UDI
Model / Reference
CW-S10-Teal FDA UDI
Description
ComfortWave Hydromassage Table, S10, Teal, Right Hand Control, 120 volt, 60 hertz FDA UDI

Identifiers

Primary DI / UDI-DI
00850054883292 FDA UDI
FDA Product Code
ISA FDA UDI
GMDN Term
Dry hydro-massage system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5660 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

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dry hydro-massage system

ComfortWave by Sidmar Manufacturing, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dry hydro-massage system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sidmar Manufacturing, Inc.

Sources (1)

  • FDA UDI fb41fdc0-9757-4539-938e-67eaba9c732d 34 fields · synced Jun 8, 2026