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Pelvital System

by Pelvital USA, Inc.

510(k) K200409

Pelvital System is a Class II device made by Pelvital USA, Inc., cleared under FDA 510(k) K200409 on 10 Jul 2020, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200409 Date10 Jul 2020ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HIR
Device class
Class II
Regulation
21 CFR Part 884.1425
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K200409

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K200409
UDI-DISize and differences
Flyte In-Home Pelvic Floor Treatment MTI-1
Pelvital USA, Inc.
MTI-100860331002018
Prescription: no
On the market
Flyte In-Home Pelvic Floor Treatment MTI-1
Pelvital USA, Inc.
MTI-100860331002001
Prescription: yes
On the market
Flyte MTI-1
Pelvital USA, Inc.
MTI-100860331002032
Prescription: no
On the market

Similar devices

Other devices filed under FDA product code HIR (Perineometer).

Other devices from Pelvital USA, Inc.

See all devices from Pelvital USA, Inc. →