FDA.reportPublic FDA data

ComfortWave

Primary DI
00850054883216
Brand
ComfortWave
Company
Sidmar Manufacturing, Inc.
Model
CW-S10-Blue
Device description
ComfortWave Hydromassage Table, S10, Blue, Right Hand Control, 120 volt, 60 hertz
Published
2023-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054883216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054883216008500548832168500548832160850054883216

GMDN Terms#

Term, Definition table
TermDefinition
Dry hydro-massage systemAn electrically-powered assembly of devices intended for large-area/whole-body massage using water jets but without wetting the patient. It includes a water tank with internal pump(s)/jets, a covering membrane which receives the water pressure, and controls (e.g., touchscreen). It may be a chair-like or bath-like device whereby the patient sits/lies on the membrane to receive therapy. The device is intended to be used in a healthcare facility for various physiotherapy/relaxation-based applications.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763-389-9594info@sidmar.com
800-330-7260info@sidmar.com

Regulatory Flags#

DUNS number
840618011
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054883001Massage Time ProMTPSBlack2023-10-28
00850054883018Massage Time ProMTPSBlack-Left2023-10-28
00850054883025Massage Time ProMTPSBlue2023-10-28
00850054883032Massage Time ProMTPSBlue-Left2023-10-28
00850054883049Massage Time ProMTPSBrown2023-10-28
00850054883056Massage Time ProMTPSBrown-Left2023-10-28
00850054883063Massage Time ProMTPSBurg2023-10-28
00850054883070Massage Time ProMTPSBurg-Left2023-10-28
00850054883087Massage Time ProMTPSCustom2023-10-28
00850054883094Massage Time ProMTPSCustom-Left2023-10-28
00850054883100Massage Time ProMTPSGray2023-10-28
00850054883117Massage Time ProMTPSGray-Left2023-10-28
00850054883124Massage Time ProMTPSGreen2023-10-28
00850054883131Massage Time ProMTPSGreen-Left2023-10-28
00850054883148Massage Time ProMTPSNavy2023-10-28
00850054883155Massage Time ProMTPSNavy-Left2023-10-28
00850054883162Massage Time ProMTPSTan2023-10-28
00850054883179Massage Time ProMTPSTan-Left2023-10-28
00850054883186Massage Time ProMTPSTeal2023-10-28
00850054883193Massage Time ProMTPSTeal-Left2023-10-28

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