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510(k) Data Aggregation
K Number
K152628Device Name
Pulse H20h!
Manufacturer
Date Cleared
2016-07-11
(300 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
TOASTER LABS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pulse™ H2Oh! personal lubricant is intended for vaginal and/or penile application to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.
This personal lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
The Pulse H2Oh! is a personal lubricant intended for overthe-counter sale. It is sold, and used, not sterile. The lubricant is colorless to slightly yellow and unfragranced.
The product is used for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.
The Pulse H2Oh! lubricant is supplied in the form of individual plastic pump canisters, called pods. A pod is ~2.5 inches tall, has a diameter of ~1 inch and contains ~6.7 ml of lubricant. The pod pump allows the user to receive an aliquot of lubricant without touching the nozzle or inside of the container.
The Pulse H2Oh! lubricant is a gel with a pH of 4.8 - 5.2, and is comprised of the following ingredients:
- Purified water
- Propanediol / Zemea Propanediol ●
- Hydroxyethylcelluose / Natrosol 250H Pharm ●
- Potassium Sorbate ●
- Chia Seed Extract ●
- Citric Acid ●
Device specifications are: color, odor, appearance, weight gain/loss % (w/w), pH, specific gravity, viscosity, osmolality, total aerobic microbial count, total yeast and mold count, absence of specified microorganisms (P. aeruginosa, S. aureus and C. albicans) and antimicrobial effectiveness.
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K Number
K152671Device Name
Pulse Aloe-ahh
Manufacturer
Date Cleared
2016-07-11
(297 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
TOASTER LABS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
for the indications for use stated in the enclosure
Device Description
Not Found
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