FDA.reportPublic FDA data

ASP

Primary DI
03760262493404
Brand
ASP
Company
SEDATELEC
Model
ASPMA320
Catalog number
113201
Device description
The ASP Multi, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on the pinna of the ear.It consists of 5 needles encased in a plastic injector. The injector itself consists of a needle guide which facilitates positioning of the ASP exactly on the selected point, and a plunger generating the impulse required for implantation.A stimulation magnet is present on the tip of the injector and may be used to activate the action of the needle or to directly stimulate the point which is to be treated. A hypoallergenic adhesive disc can also be positioned in order to protect the needle.
Published
2023-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060392000ASP TITANIUMSedatelec2006-04-26MQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760262493404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760262493404037602624934043760262493404

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture needle, single-useA sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+33472663322contact@sedatelec.com

Regulatory Flags#

DUNS number
266031462
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760262493107PREMIO 10 MOXAPREMIO 101112372016-09-22
03760262490625BAT02 Glass rodsBAT021036072024-04-25
03760262490670EASYO 1 - Multi Pressure FeelerEASYO 11123532024-04-25
03760262492902PAL130 Pressure feeler 130gPAL1301036092024-04-25
03760262492919PAL250 Pressure feeler 250gPAL2501033042024-04-25
03760262492926PAL400 Pressure feeler 400gPAL4001036102024-04-25
03760262492933PAL650 Pressure feeler 650gPAL6501036112024-04-25
03760262490557ASPASPTEST1106402023-01-12
03760262493411ASPASPMG3201132022023-01-12
03760262493428ASPASPMT3201132032023-01-12
03760262493435ASPASPMA1201132042023-01-12
03760262493442ASPASPMG1201132052023-01-12
03760262493459ASPASPMT1201132062023-01-12
03760262493466ASPASPMTEST1132072023-01-12
03760262493473ASPASPA641132082023-01-12
03760262493480ASPASPG641132092023-01-12
03760262493497ASPASPT641132102023-01-12
03760262490427ASPASPA81106362016-09-22
03760262490465ASPASPG81106372016-09-22
03760262490564ASPASPT81106382016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B5171004580Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
B517100458010Energy Flo J-Type Acupuncture NeedlesAcu MarketMQX2026-06-26
00816073022487SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023347HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023354HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023361HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023378HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023385HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023392HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023408HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023415HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023422HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023576SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023583SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073023644HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023651HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023675HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023682HyChiHealth Body World Supply Inc.MQX2026-06-23
00816073023699HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023705HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023712HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023729HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023736HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023743HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023750HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073023767HyChi - Mini 5Health Body World Supply Inc.MQX2026-06-23
00816073024221SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024344SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024351SILVERSTARHealth Body World Supply Inc.MQX2026-06-23
00816073024481SILVERSTARHealth Body World Supply Inc.MQX2026-06-23