FDA.reportPublic FDA data

Primo Passi

Primary DI
00850018480888
Brand
Primo Passi
Company
Primo Passi LLC
Model
9229
Catalog number
SK-351
Device description
An electrically powered, handheld, rechargeable massager intended for use on the breast area. The device uses vibration, with an optional heat function, to provide temporary relief of muscle tension, promote relaxation, and temporarily increase local blood circulation. The device body is constructed of soft silicone for ergonomic hand-held use and is intended for personal, non-clinical use.
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00850018480888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018480888008500184808888500184808880850018480888

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held electric massagerAn electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.

Contacts#

Phone, Email table
PhoneEmail
888-233-3198sales@primopassi.com

Regulatory Flags#

DUNS number
080607433
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000125506Primo PassiXB-8732SK-2502026-09-19
00850018480895Primo Passi9229SK-3302026-09-19
00850000125469Primo PassiJPD-FR300SK-1582026-03-27
00850065139272Primo PassiXB-8791SK-3762026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014139918QUASONIQ+Global Good, Corp.ISA2026-09-21
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088095244976843H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976913H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977073H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977143H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977213H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977383H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977453H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244977523H Smart Massage Bed3H, Co., LtdISA2026-07-29
088095244976773H Smart Massage Bed3H, Co., LtdISA2026-07-28
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08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08