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OW100S-Us

by MTS Medical AG

OW100S-Us (1000021) is a freestanding electric massager (FDA Class I; FDA product code ISA, Massager, Therapeutic, Electric) made by MTS Medical AG, cleared under FDA 510(k) K213120 on 12 Oct 2022 and listed in FDA GUDID since 29 Nov 2022 (UDI-DI 04260484571625), 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

510(k) K213120

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260484571625 UDI-DI Date29 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213120 Date12 Oct 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213120 decided 12 Oct 2022 Active
  • FDA GUDID UDI-DI 04260484571625 listed 29 Nov 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213120
  2. Listed FDA GUDID 04260484571625

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OW100S
Generic name
Freestanding electric massager
Model / Ref / Catalog
OW100S-US, 1000021
Primary DI / UDI-DI
04260484571625
510(k) Number
FDA product code
ISA
GMDN term
Freestanding electric massager
Device class
Class I
Regulation number
890.5660
GUDID distribution status
In Commercial Distribution
Size
Weight — 21 Kilogram
Depth — 459 Millimeter
Width — 400 Millimeter
Height — 218 Millimeter

Related devices

Category: Freestanding electric massager

Cleared under the same submission (K213120)

Similar devices

Other devices filed under FDA product code ISA (Massager, Therapeutic, Electric).

Other devices from MTS Medical AG

See all devices from MTS Medical AG →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)