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AffloVest 8043

by Tactile Systems Technology Inc

AffloVest 8043 is a chest-percussion airway secretion-clearing system (FDA Class II; FDA product code BYI, Percussor, Powered-Electric) made by Tactile Systems Technology Inc, cleared under FDA 510(k) K122480 on 27 Mar 2013 and listed in FDA GUDID since 8 May 2022 (UDI-DI 00816305023718), active as of 22 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 22 Oct 2026

Documents

510(k) K122480

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816305023718 UDI-DI Date8 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122480 Date27 Mar 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122480 decided 27 Mar 2013 Active
  • FDA GUDID UDI-DI 00816305023718 listed 8 May 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122480
  2. Listed FDA GUDID 00816305023718

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AffloVest
Generic name
Chest-percussion airway secretion-clearing system
Model / reference
8043
Primary DI / UDI-DI
00816305023718
510(k) Number
FDA product code
BYI
GMDN term
Chest-percussion airway secretion-clearing system
Device class
Class II
Regulation number
868.5665
GUDID distribution status
In Commercial Distribution

Related devices

Category: Chest-percussion airway secretion-clearing system

Cleared under the same submission (K122480)

and 8 more cleared under K122480

Similar devices

Other devices filed under FDA product code BYI (Percussor, Powered-Electric).

Other devices from Tactile Systems Technology Inc

  • AffloVest 6100XS

    Class II

  • AffloVest 6200S

    Class II

  • AffloVest 6300M

    Class II

  • AffloVest 6400L

    Class II

See all devices from Tactile Systems Technology Inc →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)