FDA.reportPublic FDA data

AHIP Internal Trigger Point Wand

Primary DI
00862945000404
Brand
AHIP Internal Trigger Point Wand
Company
NEW PELVIC PAIN TECHNOLOGIES
Model
1112
Device description
Therapeutic massager to internally massage trigger points in the pelvic floor musculature.
Published
2023-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor MusculaturePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862945000404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862945000404008629450004048629450004040862945000404

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic floor internal manual massagerA manual (non-powered) device intended to be inserted into the rectum or vagina and manipulated to massage myofascial trigger points of the pelvic floor muscles to relieve acute or chronic pelvic pain (e.g., myofascial pelvic pain syndrome). It is in the form of a design-shaped plastic wand and is intended to be used with disposable coverings (not included) and a water-based lubricant (not included). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(707) 874-2225dovidl@sonic.net

Regulatory Flags#

DUNS number
031751981
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true