Transcend P4 Battery

by Somnetics International, Inc

Transcend P4 Battery (503026) is a Class II device made by Somnetics International, Inc, cleared under FDA 510(k) K132127 on 17 Oct 2013 and listed in FDA GUDID since 3 Jan 2019 (UDI-DI M9505030260), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberM9505030260 UDI-DI	Date3 Jan 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK132127	Date17 Oct 2013Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K132127

Across registries

2 registries list this device

FDA 510(k) K132127 decided 17 Oct 2013 Active
FDA GUDID UDI-DI M9505030260 listed 3 Jan 2019 Listed

Timeline

2 dated events

17 Oct 2013 Cleared FDA 510(k) K132127
3 Jan 2019 Listed FDA GUDID M9505030260

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Transcend
Generic name: Portable/mobile rechargeable battery pack
Model / Ref / Catalog: P4 Battery, 503026

Primary DI / UDI-DI: M9505030260
510(k) Number: K132127
FDA product code: BZD
GMDN term: Portable/mobile rechargeable battery pack

Device class: Class II
Regulation number: 868.5905
GUDID distribution status: In Commercial Distribution

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Properties

Lot / batch number

Other properties (14, all answered No)