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PCD Boot OS1-29 4 Cell Custom Boot

by Normatec Industries, LP

PCD Boot OS1-29 4 Cell Custom Boot (20120) is an intermittent venous compression system (FDA Class II; FDA product code JOW, Sleeve, Limb, Compressible) made by Normatec Industries, LP, cleared under FDA 510(k) K161346 on 15 Jun 2016 and listed in FDA GUDID since 7 Nov 2016 (UDI-DI 00817369022457), 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) K161346

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 Number00817369022457 UDI-DI Date7 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161346 Date15 Jun 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161346 decided 15 Jun 2016 Active
  • FDA GUDID UDI-DI 00817369022457 listed 7 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161346
  2. Listed FDA GUDID 00817369022457

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PCD Boot
Generic name
Intermittent venous compression system
Model / Ref / Catalog
OS1-29 4 Cell Custom Boot, 20120
Primary DI / UDI-DI
00817369022457
510(k) Number
FDA product code
JOW
GMDN term
Intermittent venous compression system
Device class
Class II
Regulation number
870.5800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intermittent venous compression systemSequential venous compression system

Cleared under the same submission (K161346)

and 8 more cleared under K161346

Similar devices

Other devices filed under FDA product code JOW (Sleeve, Limb, Compressible).

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

  • Prescription use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)