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Pulse Boot Pulse Tall Zippered Boot Black

by Normatec Industries, LP

Pulse Boot Pulse Tall Zippered Boot Black (20001) is a sequential venous compression system (FDA Class II; FDA product code IRP, Massager, Powered Inflatable Tube) made by Normatec Industries, LP, cleared under FDA 510(k) K160608 on 13 Apr 2016 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00817369020118), 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) K160608

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 Number00817369020118 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160608 Date13 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160608 decided 13 Apr 2016 Active
  • FDA GUDID UDI-DI 00817369020118 listed 13 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160608
  2. Listed FDA GUDID 00817369020118

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pulse Boot
Generic name
Sequential venous compression system
Model / Ref / Catalog
Pulse Tall Zippered Boot Black, 20001
Primary DI / UDI-DI
00817369020118
510(k) Number
FDA product code
IRP
GMDN term
Sequential venous compression system
Device class
Class II
Regulation number
890.5650
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intermittent venous compression systemSequential venous compression system

Cleared under the same submission (K160608)

and 8 more cleared under K160608

Similar devices

Other devices filed under FDA product code IRP (Massager, Powered Inflatable Tube).

Other devices from Normatec Industries, LP

  • Hyperice PRO26-Sh

    Class II

  • Hyperice PRO26-St

    Class II

  • Hyperice PRO26-Tl

    Class II

  • Hyperice PRO26-Ph

    Class II

See all devices from Normatec Industries, LP →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)