Pedia Pals, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Pedia Pals, Inc. makes
Pedia Pals, Inc. manufactures pediatric medical devices, including blood pressure cuffs designed for children and ENT (ear, nose, throat) examination tools such as nasal and oral specula. Their products are tailored for clinical use in assessing vital signs and conducting otolaryngological procedures in pediatric patients.
The company’s portfolio includes Class I and Class II devices, with submissions recorded in the FDA’s 510(k) registry. These products are regulated under U.S. medical device laws and are listed in the FDA’s public clearance database.
Catalogue
Pedia Pals Ref K911650
Regimes: 510(k) Registry: 510(k)Blood Pressure Cuff 3 Ref K951041
Regimes: 510(k) Registry: 510(k)Speculum, Ent (S3) Ref K951049
Regimes: 510(k) Registry: 510(k)Blood Pressure Cuff 1 Ref K951039
Regimes: 510(k) Registry: 510(k)Speculum, Ent (S3) Ref K951050
Regimes: 510(k) Registry: 510(k)Blood Pressure Cuff 2 Ref K951040
Regimes: 510(k) Registry: 510(k)Pedia Pals, Incorporated Ref K950086
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pedia Pals, Inc. have in the registry?
The registry currently lists 7 devices for Pedia Pals, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pedia Pals, Inc.'s devices?
Among its 7 most recently registered devices, Pedia Pals, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Pedia Pals, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Pedia Pals, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Pedia Pals, Inc. in the registry?
The most recently registered devices listed for Pedia Pals, Inc. include PEDIA PALS, BLOOD PRESSURE CUFF 3, SPECULUM, ENT (S3) and BLOOD PRESSURE CUFF 1.